Associate Director, Biostatistics Resume Sample
Godfrey Harvey
9187 Murray Manor,
Chicago,
IL
+1 (555) 906 2129
Work Experience
Associate Director, Biostatistics
12/2015
-
PRESENT
New York, NY
- Good written and oral communication skills including grammatical/technical writing skills
- Work with the internal / CRO statisticians and programmers to ensure the quality of CRO deliverables and on QA of data outputs
- Function as lead statistician in global registration trials and manage all related statistical activities
- Manage contract statisticians in the group. Provide mentoring and oversee work assigned
- Strong teamwork ability/commitment and individual initiative
- Strong organizational skills with ability to effectively manage multiple studies
- Lead the biostatistics function and personnel to develop and execute statistical strategy, design, and analyses for clinical trials
Associate Director Biostatistics
07/2011
-
11/2015
Detroit, MI
- Manage CROs regarding statistical activities to ensure timely delivery of quality analysis results
- Work with department head, peer management, and employees to develop, implement, and maintain department standards and practices
- Help design data capture methods and select appropriate study endpoints for clinical programs
- Attend meetings with regulatory agencies and support/defend clinical programs
- Collaborate with researchers and thought leaders in the planning of clinical development programs and the publication of study data
- Present study results to internal and external audiences
- Be able to conduct independent research and resolve statistical methodological issues
- Develop statistical programs as necessary to perform analysis, prepare data displays, verify data accuracy and validity
- Recruit, develop, and supervise internal and external statistical resources to achieve department functional goals
Director / Associate Director, Biostatistics
04/2008
-
02/2011
Chicago, IL
- Provide general guidance on definition and documentation of key derived variables needed to support production of tables, listings, and graphs (TLG). Effect consistency of data collection and analysis across project or area. Analysis datasets that are quality controlled, sufficient to produce TLG for reports, and consistent within projects
- Represents Biostatistics on CDT/Asset teams and provides professional statistical support to clinical development team
- Ensure timeliness and high quality of Biostatistics deliverables. Is able to handle requests from regulatory agencies, health authorities, across multiple drug programs, often under tight timelines
- Able to make decisions at CDT level across a variety of studies with minimal input from line or project manager. - Able to work with others to identify and resolve areas of concerns
- Takes initiative to communicate issues within or across multiple project team(s). Is able to handle large volume of highly complex tasks with minimal supervision
- Contributes to the long-term growth strategy of the department
- Provides mentorship to junior biostatisticians in the department
Education
University of Medicine and Dentistry of New Jersey - Piscataway / New Brunswick Campus
2003 - 2007
Science's Degree in Biostatistics
Professional Skills
- Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills
- Excellent analytical, problem solving and organization skills with the ability to work simultaneously in multiple tasks
- Strong interpersonal and communication skills bridging scientific and business needs
- Detail-oriented with strong quantitative, written, and communication skills
- Excellent interpersonal communication skill to build relationship cross-functionally and collaborate effectively
- Proficient SAS programming skills, solid understanding of CDISC models and standards
- Efficient training/teaching/communication skills
How to write Associate Director, Biostatistics Resume
Associate Director, Biostatistics role is responsible for interpersonal, software, clinical, programming, health, leadership, statistics, regulatory, development, sas.
To write great resume for associate director, biostatistics job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Associate Director, Biostatistics Resume
The section contact information is important in your associate director, biostatistics resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Associate Director, Biostatistics Resume
The section work experience is an essential part of your associate director, biostatistics resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous associate director, biostatistics responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular associate director, biostatistics position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Associate Director, Biostatistics resume experience can include:
- Evaluates the effectiveness of Biostatistics programs, policies, and processes to meet evolving stakeholder needs
- Provides proactive expertise, coaching, and counseling to stakeholder leaders, employees, and peers on complex Biostatistics and stakeholder issues
- Provides directions to project teams using statistical expertise and project knowledge
- Maintains close collaboration and working relationships with stakeholders
- Leverages existing Biostatistics programs, policies, and procedures to create value-added solutions for Biostatistics
- Manages outside CROs and contractors
Education on an Associate Director, Biostatistics Resume
Make sure to make education a priority on your associate director, biostatistics resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your associate director, biostatistics experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Associate Director, Biostatistics Resume
When listing skills on your associate director, biostatistics resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical associate director, biostatistics skills:
- Evidence of strong management skills, as shown through management of multiple projects and proven ability to manage, mentor, and motivate staff
- Strong interpersonal skills and demonstrated ability to work as a member of a team
- Excellent technical and consultation skills with strong records of publications in TM and Research areas
- Proven ability to effectively represent Biostatistics and Programming in multidisciplinary or cross-functional meetings
- Strong interpersonal and communication skills (verbal and written in English), comfortable around senior management
- Strong communication and interpersonal skills; ability to interact with cross-functional teams
List of Typical Experience For an Associate Director, Biostatistics Resume
1
Experience For Associate Director Biostatistics Resume
- Support creation and validation of e-Submission requirement (i.e., annotated CRF, data export files, define document, etc.)
- Experience in Phase 1 – 3 clinical trials and observational studies in pharmaceutical environment
- Experience in design and development of statistical analysis plans, study protocols, clinical study reports
- Ensure successful completion of programming (tables, listings and graphs) for statistical deliverables
- Review/write Randomization and Blinding Plans
- Review/write charters for Data Monitoring Committee (DMC)
2
Experience For Manager / Associate Director, Biostatistics Resume
- Perform quality control on derived variables being analyzed
- Recommends external statistical experts for consultation
- Provides guidance to employee's development plan and carries out performance review and feedback
- Leverages best practices in Biostatistics management to enhance efficiencies
- Manages team conflicts to resolution and improved team collaboration
- Manages conflicts with external partners/customers
- Represents Biostatistics function at cross-functional meetings
- Oversees/coordinates biostatistical activities on global submission teams
3
Experience For Director / Associate Director, Biostatistics Resume
- Partners with senior line management to shape Biostatistics strategy in alignment with the business strategy
- Works closely with stakeholder leaders to develop and implement high impact business initiatives
- Manage biostatisticians within the therapeutic area
- Reviews protocols and other study documents that are developed in collaborations of business alliances. Provides statistical supports for regulatory submissions in the collaborations
- Independently reviews whole protocol and interfaces with clinicians and other functions to understand study requirements and study design elements including sample size calculations, analysis methods, study durations etc. for multiple studies ]
- Develops and/or reviews statistical documents for multiple clinical trials, including SAPs, TLG shells and specifications of variable derivation. Support clinical trial related publications
4
Experience For Associate Director, Biostatistics Immunology Resume
- PhD with 5+ years or MS with 10+ years of experience required in related discipline or in the pharmaceutical industry/CRO environment
- Works with the internal/CRO statisticians and programmers to ensure the quality of CRO deliverables and on QA of data outputs
- Functions as lead statistician in global registration trials and manages all related statistical activities
- Review draft abstracts and manuscripts according to deadlines, and when appropriate, serve as an Author. In some cases, develop abstracts in close collaboration with external medical writers. Serve as group’s expert on Methods sections
- Manage effectively one’s projects and quickly accommodate to changing priorities, and also to meet tight deadlines while maintaining high quality standards
- Knowledge of linear models, including repeated measures analyses and mixed effects models as well as categorical data analysis required; experience with time to event data and exact methods desirable
- Experience in late-phase pivotal trials, post-approval trials, and/or registries
- Knowledge of, and experience with CDISC standards, medical terminology, FDA regulatory process (e.g., “milestone” meetings), and applicable ICH guidelines
5
Experience For Associate Director, Biostatistics Resume
- A person who can understand and clearly communicate complex information
- Excels in a collaborative team-oriented environment
- Work in a multidisciplinary study team to provide timely and quality support for analysis and reporting of clinical studies, ad hoc requests, manuscripts, annual reports and other company’s publication needs
- Writes or reviews key study documents to ensure optimal statistical presentation and compliance. These documents include, but are not limited to, protocols, analysis plans, tables, listings, and figure (TLF) specifications, study reports
- Ensures efficient planning, execution and reporting of clinical studies and statistical review of critical documents such as CRFs, Data Validation Plans, SDTM/ADaM data specifications, TLFs
- Ensures statistical analyses performed in accordance with the protocol, statistical analysis plan, good statistical practice, and available regulatory guidelines
- Provides (executive) top line reports of study results
- Serves as the global lead statistician in the support of trial Phases I-III of drug development for a therapeutic area
- Manages multiple studies within an indication or therapeutic area
6
Experience For Associate Director Biostatistics Resume
- Serves as an advisor to statisticians assigned to the project to ensure high quality and timely deliverables
- Guides global staff in the preparation of Statistical Analysis Plans. Shepherds the plan through clinical review to ensure worldwide organizational acceptance of the statistical design, endpoints, and proposed analyses
- Ensures consistency and adherence to standards within a project
- Provides statistical support for Health Authority requests, publications, presentations, and posters at medical conferences/symposia, as assigned
- Impacts directly on overall business and Biostatistics performance through the ability to influence and work in a consultative manner with senior stakeholders
- Timely, efficient clinical development programs. Quality drug development milestone transitions, submissions, re-ducing the time and cost for development/ registration/ commercialization and increasing probability of approval
- Increased quality of decisions: in-licensing, early stop-ping of non-promising trials/indications
- Increased commercial value of brands
7
Experience For Manager / Associate Director, Biostatistics Resume
- Timely, efficient clinical development programs. Quality drug development milestone transitions, submissions, reducing the time and cost for development/ registration/ commercialization and increasing probability of approval
- Knowledge of modern statistical methods and innovative clinical trial designs and experience in research on innovative statistical methods for clinical trial design and analysis to support new drug development
- Independently reviews whole protocols and interfaces with clinicians and other functions to understand study requirements and design study elements including sample size calculations, analysis methods, study duration etc. for multiple studies
- Develops and/ or reviews statistical documents for multiple clinical trials, including SAPs, TLG shells and specifications of variable derivation. Support clinical trial related publications
- Independently provides statistical and validation support for analysis datasets, statistical tables, figures and listings. Performs and validates statistical analysis. Independently reviews CSRs and performs data interpretation
- Ensure mentoring and development of staff. Encourage personal development in the context of project work
- Works with the internal / CRO statisticians and programmers to ensure the quality of CRO deliverables and on QA of data outputs
- Functions as lead statistician in global registration trials and manage all related statistical activities
8
Experience For Director / Associate Director, Biostatistics Resume
- Leads preparation of inputs for regulatory documents and helps to prepare for meetings with health authorities. Leads preparation of responses to health authorities including identification and execution of new analysis required for responses
- Working as leading statistician on multiple studies/projects across different therapeutic areas. Contribute to clinical trial design, protocol development and Clinical Study Report (CSR)
- Participate study related activities and provide statistical consultation, input and guidance to cross-functional groups
- Develop and/or review statistical documents or deliverables for clinical trials including Statistical Analysis Plan (SAP) and integrated summaries of drug efficacy and safety, TFLs, interim analysis plan and others
- Manage CRO statisticians and internal biostatistics team, including junior statistician, contract statistician and programming team in support of biostatistics operational activities
9
Experience For Associate Director, Biostatistics Immunology Resume
- Provide statistical expertise by identifying potential issues, providing recommendations and bring in statistical experts external for relevant issues as needed
- Provide guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package
- Oversee statistical support to multiple project teams
- Collaborate with clinical and regulatory leads in defining general strategic approach, creating clinical development plans (CDP), and producing individual protocols
- Oversee execution of statistical analyses, preparation of the statistical methods and results sections for clinical study reports (CSR), and production of overall summaries
- Review and approve key results memos and statistical conclusions
- Ensure statistical representation at regulatory or other external meetings
- Complete data package relevant for submission or making key decisions. Statistical deliverables consistently compliant, in timing and quality, with SOPs and departmental standards
- Provide general guidance on definition and documentation of key derived variables needed to support production of tables, listings, and graphs (TLG)
10
Experience For Associate Director, Biostatistics Resume
- Effect consistency of data collection and analysis across project or area
- Analysis datasets that are quality controlled, sufficient to produce TLG for reports, and consistent within projects. General compliance with Sanofi-Aventis standard data models, e.g. CIDSC
- Plan and track project activities, timelines, and resource use across projects
- Provide justification for planned resource needs. Seek to optimize resource utilization and capacity
- Learn and apply techniques to promote teamwork, quality, and motivation. Staff compliance with SOPs and departmental policies
- Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOP
- Within area of control, update procedures or practices as needed to remain in compliance
List of Typical Skills For an Associate Director, Biostatistics Resume
1
Skills For Associate Director Biostatistics Resume
- In-depth programming skills of SAS, R, or other statistical software
- Effectively mentor senior staff to direct and promote teamwork in a multi-disciplinary team setting
- Prior experience in NDA/BLA submissions and responding to FDA/regulatory requests
- Pharmaceutical experience, including significant interactions with regulatory bodies and experience in neuroscience area
- Work in a collaborative environment, desire to learn and improve skills
- Ph.D. in Biostatistics/Statistics with 4 years experience in industry or MS with 6 years of experiences
- Work effectively with leaders in other functional areas
- Experience in providing statistical input into protocol study design, writing analysis plans, and the regulatory and scientific reporting of clinical research
- Experience managing and implementing working relationships with external agencies, such as CRO, consultant groups, and research committees
2
Skills For Manager / Associate Director, Biostatistics Resume
- Experience in managing statistical and programming activities of CROs
- Good understanding of various functions and expert groups contributing to drug development
- Experience in the development of statistical plans, programming, and analyses of Phase I-IV clinical trials
- Experience in planning and preparation of integrated summary documents- ISE, ISS
- Experience in contributing to NDAs/BLAs submission and defense is required
- Experience supporting global regulatory submissions is required. Knowledge of CDISC submission and integrated safety and efficacy summary
- Knowledge and experience in meeting regulatory guidelines, both FDA and international regulatory agencies
3
Skills For Director / Associate Director, Biostatistics Resume
- Very good understanding of all phases of clinical development, and processes in data science
- Experience in pharmaceutical, biotech, and/or CRO setting
- Comprehensive experience of SAS programming and R/S language
- Demonstrated broad knowledge and superior understanding of advanced statistical concepts and techniques
- Demonstrated in-depth understanding of the regulatory drug submission / approval process regionally and globally
- Experience with linear and nonlinear models, Bayesian methodology, statistical decision theory, modeling and simulation, and model-informed drug development
4
Skills For Associate Director, Biostatistics Immunology Resume
- Experience in clinical pharmacology studies, pharmacokinetics (PK), and PK/PD modeling
- Experience in pharmaceutical, biotech, and/or CRO setting
- Experience in supporting Phase 1 studies as well as early-phase studies to support development program decisions (“go/no go”) and dose selection
- Proficiency in SAS programming - StatExact and R experience desirable
- Effective corporate use of statistical thinking
- PH.D. (MS) in statistics or related discipline with 8+ (10+) years of pharmaceutical experience, including significant interactions with regulatory bodies
- In-depth experience of Base SAS,SAS/STAT, and SAS/GRAPH
5
Skills For Associate Director, Biostatistics Resume
- Experience of Development, program design and data analysis and interpretation
- Experience of regulatory interactions and/or submissions
- Experience of project management as global statistical leader, preferably exposed to a multicultural environment
- Excellent knowledge of ICH/GCP and other relevant regulations
- Past frequent interaction with FDA and BLA/NDA experience
- Or Ph.D. and 4 years of experience
- Work independently, or with other statistical departmental members or consultants, to develop effective statistical approaches applicable to project
- Experience in Neuroscience clinical trials
- Validate/perform SAS programming for key data analyses
6
Skills For Associate Director Biostatistics Resume
- PH.D. (MS) in statistics or related discipline with 6+ (9+) years of pharmaceutical experience, including significant interactions with regulatory bodies
- Ph.D. in Statistics or Biostatistics with 10+ years of direct experience in biotechnology industry
- Guide data management and programming in developing standards for building databases, edit checks, and statistical programming for data analyses
- Contributes to Clinical Development Plans, submissions and post-submission strategies, preparations and defense, ensuring quality and timing thereof
- High impact by leading the statistical scientific: plan-ning, evaluation, risk mitigation for and health authority acceptability for development programs
7
Skills For Manager / Associate Director, Biostatistics Resume
- Advocate application of statistical thinking in decision-making
- Comprehensive expertise in drug development, including knowledge of interfaces and interdependencies of clinical development with other functions
- MS with 8 or PhD with 6 years or more working on clinical trials
- A broad understanding of the applications of Statistics to Research & Development
- Understand and develop statistical and patient-based models, using the latest tools and methodologies
- Provides all required statistical support and deliverables by supervising another statistician in that role, or as a member of study team him/herself
- Contributes to, and provides training on new departmental statistical topics, SOPs, WPs
- Manages contract statisticians in the group. Provides mentoring and oversees assigned work
- Develop departmental metrics and tracking systems for data quality assurance
8
Skills For Director / Associate Director, Biostatistics Resume
- Develop standard reporting programs and standard CRF’s in collaboration with cross-functional groups
- Communicate statistical information to non-scientists, willingness to educate internal teams
- Experience with standard statistical methods including but not limited to parametric and non-parametric analysis, survival analyses, longitudinal data analysis, logistic regression, methods used in handling missing data, MMRM, GEE, multiple testing procedures, multivariate statistics, meta-analysis and categorical data analysis
- Communicate statistical information to non-scientists, willingness to educate internal team
- Experience with statistical methods including but not limited to parametric and non-parametric analysis, survival analyses, longitudinal data analysis, categorical data analysis, multivariate statistics, meta-analysis, methods used in handling missing data, multiple testing procedures, and adaptive design,
- Knowledge of the technical and regulatory requirements related to the role
- PhD in Statistics, Biostatistics, or related fields
9
Skills For Associate Director, Biostatistics Immunology Resume
- Represent Biostatistics on CDT/Asset teams and provides professional statistical support to clinical development team. Ensure timeliness and high quality of Biostatistics deliverables. Able to handle requests from regulatory agencies, health authorities, across multiple drug programs, often under tight timelines
- Able to make decisions at CDT level across a variety of studies with minimal input from line or project manager. Able to work with others to identify and resolve areas of concerns. Takes initiative to communicate issues within or across multiple project team(s). Able to handle large volume of highly complex tasks with minimal supervision
- Lead organization-wide led initiatives e.g. Quality, standardization etc
- Ph.D. or MS in Statistics, Biostatistics or equivalent required
- Demonstrates a customer focus by partnering with customers as a trusted consultant and serves as an integral part of customer’s decision-making process (serving customers)
- Respond to regulator’s inquiries for products undergoing registration and approved products
- Familiarity with statistical software such as SAS, R or SPlus is required
- Broad knowledge of medical/biological terminology and clinical trial designs and competitive landscape in relevant therapeutic areas
- PhD in Statistics/Biostatistics and at least 5 years of pharmaceutical experience or a MS in Statistics/Biostatistics and at least 8 years of pharmaceutical experience
10
Skills For Associate Director, Biostatistics Resume
- Excellent presentation skills to groups of varied size and make up
- Assay validation experience is highly desired
- Pre-clinical and non-clinical experience is required
- Extensive experience in population genomics, including unknown and admixed ancestry analyses
- Solid knowledge of ASA and other statistical tools
- Experience from similar work within a pharmaceutical company or CRO is preferable
- Experience in US and/or Non-US submissions
- Pharmaceutical clinical trial experience
- Proven ability to innovatively apply technical principles, theories, and concepts to pharmaceutical clinical development and life cycle management
List of Typical Responsibilities For an Associate Director, Biostatistics Resume
1
Responsibilities For Associate Director Biostatistics Resume
- Championing and supporting the TM group
- Provide leadership to the biometrics team on multiple programs or key studies; review work of statisticians supporting this work
- Perform or oversee power/sample size calculations to determine appropriate trial size; run simulations to assess operating characteristics of designs
- Develop ad hoc analysis plans and ensure analyses are performed appropriately by programming staff
- Proficiency in R programming required, as well as Perl, SAS, S+, C++, UNIX/LINUX, Oracle and/or MySQL
- Serve as departmental representative on division or corporate-wide teams
2
Responsibilities For Manager / Associate Director, Biostatistics Resume
- PH.D. (MS) in statistics or related discipline
- Collaborate within Biostatistics team and with cross-functional teams (clinical scientists, statistical programmers, clinical operations and clinical data management) to plan clinical studies, analyze and interpret clinical study data
- Partner with CMO to develop department standards to ensure statistical integrity of project deliverables such as regulatory statistical and date requirements
- Contribute in strategy discussion in cross-functional project settings and act as indication lead statistician
- Author and/ or review statistics section in the protocol, SAP and DMC charter. Lead regulatory responses and submissions to the FDA and other regulatory agencies
- Monitor project progress and ensure proper resource allocation for successful project deliverables against goals and timelines
3
Responsibilities For Director / Associate Director, Biostatistics Resume
- Advanced knowledge of statistical methods in clinical study designs, clinical data analyses (from Phase I through Phase IV), including statistical procedures in analysis software (e.g., SAS)
- Great knowledge of clinical operations, data management, and clinical study report preparation workflow
- In-depth knowledge of statistical analysis methods and results/data presentation formats of clinical data
- In-depth knowledge of regulatory regulations and guidelines
- Advanced knowledge of SAS, CDISC requirements for SDTM and ADaM
4
Responsibilities For Associate Director, Biostatistics Immunology Resume
- Proficiency in MS Word, Excel, PowerPoint, and Project
- Provide estimates for proposals and contracts
- Consult/review/write statistical sections of protocols
- Assist in protocol study design (determine sample sizes for all phases of trials )
- Write Statistical Analysis Plans (SAP)
- Provide SAS code for statistical models
- Interpret results from analysis
- Review Clinical Study Reports (CSR)
- Provides guidance and direction to team members to ensure departmental and client/project goals are met
5
Responsibilities For Associate Director, Biostatistics Resume
- Utilizes metrics to drive and enhance performance
- Coaches, develops and provides continuous feedback to team members
- PH.D. (MS) in statistics or related discipline with 6+ (8+) years of experiences in pharmaceutical industry and clinical research. Experience and proven success in leading complex/large submissions is required. Demonstrated leadership, project management, and interpersonal skills
- Actively provide statistical support to Celgene Research and Development
- Develop novel solutions to challenge technical problems from TM an NCES projects. Generate technical reports and publication manuscripts so the new methods can be validated in the statistical community internally and externally to apply in real data
6
Responsibilities For Associate Director Biostatistics Resume
- Develop and deliver statistical training courses to research scientists and R&D staff. Supporting development and implementation of end-user tools
- Partner with the Head of Biometrics to develop department standards to ensure statistical integrity of project deliverables such as regulatory statistical and data requirements
- Advanced knowledge of statistical methods in clinical study designs especially Oncology trials, clinical data analyses (from Phase I through Phase IV), including statistical procedures in analysis software (e.g., SAS)
- MS in statistics, biostatistics, or related field with 10+ years of experience, or PhD with 8+ years of experience
- Address technical issues effectively with written and verbal communication
- Explain statistical issues effectively to technical and non-technical staff
- Strong knowledge of FDA regulations, ICH GCP guidelines, the drug development process
- In-depth knowledge of statistical analysis methods and results/data presentation formats of clinical data for regulatory submissions
- In-depth knowledge of regulatory guidelines, Integrated summaries of Efficacy and Safety
7
Responsibilities For Manager / Associate Director, Biostatistics Resume
- Provide career growth opportunities for staff
- Define resource needs and determine use of in-house, contractors, or CRO
- Support, and identify need for, the development and improvement of department tools, templates, guidelines, SOPs, and systems
- Knowledgeable in disease areas under study (e.g. available treatments, course of disease, endpoints, analyses used for previous submissions)
- To provide high-quality statistical consultation and services to all Teams from discovery through POC to loss of exclusivity
- To consistently employ innovative study designs and the best statistical practices for data analysis and interpretation in order to maximize the value of our medicines
8
Responsibilities For Director / Associate Director, Biostatistics Resume
- When required, make credible recommendations to Teva senior management about the strategic direction of TM statistics and bioinformatics
- Reports to the Head of the Translational and Non-clinical Statistics within Global Biostatistics
- Partners with statistics Group Heads, global disease area heads and local leaders, as required
- Responsible for oversight of the input from collaborators, consultants and contract staff, as required
- Technical leader accountable for developing robust TM statistics methodology in collaboration with the TM unit to apply to compounds in development throughout the pipeline, including those developed with a companion diagnostic
- Responsible, together with TM, to develop a bioinformatics company-wide solution
- Advise the TM unit on personalized medicine statistical and bioinformatics methodology, including program and study design, data analysis and multivariate predictive modeling
9
Responsibilities For Associate Director, Biostatistics Immunology Resume
- Work closely in collaboration with the TM experts to design and execute pharmacogenomics and biomarker studies, including targeted genotyping, GWAS, whole genome sequencing, RNA expression, protein expression and other biomarkers of interest
- Support QC of vendors and methodology across the continuum of TM modalities
- Proactively identify challenges and develop contingency plans as appropriate
- Contribute to a world class global statistics organization with responsibilities that span drug development team activities from Discovery through POC through LOE
- Demonstrate and promote critical statistical thinking, with a particular focus on delivery to ensure developing and sustaining the value of medicines and healthcare solutions
- Promote great science, innovation, efficient design and quantitative decision making in partnership with other lines
- Support the creation and maintenance of a network of world-leading external statistical advisors and consultants with focus on TM and Bioinformatics
10
Responsibilities For Associate Director, Biostatistics Resume
- Collaborate with scientists, clinicians and clinical pharmacologists to drive quantitative approaches throughout clinical development and commercial support
- Encourage and support business-aligned publication of innovative science and statistical application
- In partnership with the TM Leadership and the Clinical LT, seek opportunities to engage with and influence regulators
- Develops and implements the plan to achieve objectives
- For assigned projects, provides all statistical support and deliverables by supervising another statistician in that role, or as a member of study team him/herself
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