Manager, Biostatistics Resume Sample
Eugenia Ankunding
2025 Walter Heights,
Phoenix,
AZ
+1 (555) 848 0552
Work Experience
Manager, Biostatistics
04/2018
-
PRESENT
Dallas, TX
- Statistical lead on multiple medical affairs studies and publications
- Lead the coordination of analyses for study report and other documents and provide programming and validation support of these analyses
- Provide statistical expertise and guidance to internal and external stakeholders on ad hoc data analysis requests and publication/presentation efforts related to the medical affairs team
- Research and recommend novel statistical methodology and/or approaches useful for medical affairs
- Represent Biostatistics on multiple medical affairs project teams and coordinate/communicate with management and other team members regarding project status and timeline update
- Provide timely and scientifically sound statistical expertise to clinical development projects and develop/execute statistical strategy, design, and analyses for clinical trials
- Work with biostatistics compound/therapeutic area lead, peer management, and employees to develop, implement, and maintain department standards and practices
- Develop/write statistical analysis plans and provide data interpretation
Senior Manager, Biostatistics
01/2014
-
02/2018
Chicago, IL
- Develop statistical programs as necessary to perform analysis, prepare data displays, verify data accuracy and validity of analyses performed by statistical programming
- Help design data capture methods and select appropriate study endpoints for clinical programs
- Manage CROs regarding statistical activities to ensure timely delivery of quality analysis results
- Respond to statistical questions from regulatory agencies
- MS or PhD in biostatistics, statistics, or mathematics
- Experience in biostatistics in clinical development and drug development experience in oncology
- Advanced and broad knowledge of statistical methods, along with understanding of industry practices related to drug development
Senior Manager Biostatistics
03/2007
-
10/2013
Chicago, IL
- Excellent verbal, written, and presentation skills including the ability to clearly describe advanced statistical techniques and interpret results
- Occasional drives to site locations, frequent travels both domestic and international
- Constant interactions with associates and clients required
- Exposure to high pressure deadlines
- Intense concentration required
- When necessary, work additional hours to meet timelines
- Exposure to and use of electrical equipment required constantly
- Experience in statistical programming in a pharmaceutical company or contract research organization
- Advanced and broad knowledge of SAS, along with understanding of industry practices related statistical analyses, programming, and programming documentation
Education
University of Medicine and Dentistry of New Jersey - Piscataway / New Brunswick Campus
2002 - 2006
Master's Degree in Biostatistics
Professional Skills
- Excellent writing and communication skills, and demonstrated interpersonal skills
- Very good English skills, analytical thinking, team and communication skills
- Strong simulations experience/skills
- Strong skills in organizing, planning, problem solving
- Excellent influence and leadership skills, with a track record of collaboration with scientists and researchers at Biostatistician level
- Training/consulting skills with scientists/clinicians
- Proficient SAS programming skills, solid understanding of CDISC SDTM and ADAM models and standards
How to write Manager, Biostatistics Resume
Manager, Biostatistics role is responsible for programming, sas, presentation, reporting, training, integration, database, oncology, manufacturing, design.
To write great resume for manager, biostatistics job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Manager, Biostatistics Resume
The section contact information is important in your manager, 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 Manager, Biostatistics Resume
The section work experience is an essential part of your manager, 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 manager, 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 manager, biostatistics position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Manager, Biostatistics resume experience can include:
- Proficient in SAS Programming (including macro language) with two or more years of experience in SAS Mixed Models Procedures
- Proven understanding of standard operating procedures, process and quality control associated with biostatistics in the pharmaceutical industry
- Experience in managing a Statistics team
- Experience within the AMNOG process (GBA-advice meetings, value dossier development/medical writing, oral hearings)
- Hands-on experience in CDISC standards and datasets (SDTM, ADaM)
- Experience in oncology clinical trials and data derivations
Education on a Manager, Biostatistics Resume
Make sure to make education a priority on your manager, biostatistics resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your manager, 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 Manager, Biostatistics Resume
When listing skills on your manager, 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 manager, biostatistics skills:
- Excellent programming skills in SAS or R
- Strong communication skills and the ability to write technical reports
- ≥ 4 years of industry working experience in biostatistics in clinical development and drug development experience
- Management Experience: 1 to 2 years’ experience
- Sound computational skills R
- Programming experience with SAS
List of Typical Experience For a Manager, Biostatistics Resume
1
Experience For Senior Manager, Biostatistics Resume
- Writing or reviewing statistical analysis plans for protocols
- Writing statistical sections for protocols
- Provide protocol training at investigator meetings
- Provide statistical consulting for other departments in the company
- Support publication and other marketing strategies
2
Experience For Manager Biostatistics Resume
- Preparation and participation of oral hearings during the AMNOG process
- Strategic input into clinical trial development plan (Phase II, IIb, III - planning, conception and interpretation of study results)
- Familiar with the contract specifications and communicates any out of scope requests appropriately
- Works closely with scientists in translational research and clinical development to write study protocols and design experiments, collaborate on biomarker strategy, study design, methodology, data analysis, and interpretation
- Evaluate Engagement: Participates in the evaluation of client engagements to review the original work plan, budget, consultant contributions, client responses, and the potential for future work
- Interact with the clinical / regulatory functions to define study endpoints and perform relevant sample size calculations. Learn key clinical and regulatory considerations, ensure that planned statistical methods are applicable, and communicate important statistical considerations to clients
- Provide guidance, either personally or through a junior member of the statistical team, on definition and documentation of derived variables needed to produce planned TFL. Assume responsibility for accuracy of derived variables. Effect consistency of data collection and analysis within project
- Plan and track project activities, timelines, and resource use. Provide justification for planned resource needs. Seek to optimize resource utilization
- Provide technical direction and mentoring to staff. Maintain awareness of industry standards and regulatory requirements and communicate within team. Encourage personal development in the context of project work. Learn and apply techniques to promote teamwork, quality, and motivation
3
Experience For Senior Manager Biostatistics Resume
- Active research interest in area related to clinical trial. Advises all relevant employees about the procedures surrounding retention of data, records, and information for employees in their group. Participates in Regeneron task forces and cross-functional operational excellence initiatives
- Provides statistical expertise and input to drug development programs, including the design of translational research / biomarker analysis plans, and analyses requiring advanced statistical methodologies
- Works closely with scientists in translational research and clinical development to write study protocols and design experiments, collaborate on biomarker strategy, study design, methodology, data analysis and interpretation
- Industry experience
- PhD in biostatistics, statistics, or mathematics
- Perform sample size calculations
- Represent the biostatistics department at internal and external meetings
4
Experience For Senior Manager, Biostatistics Programming Resume
- Support global reimbursement activities
- Preparation of GBA consultations
- Close collaboration and alignment with Value Dossier Team (Market Access, Medical, Regulatory, and Biostatistic on an international level)
- Analysis of clinical trial data (notably on outcome research) with regard to disease and product profile as well as company strategy
- Analysis, workup and presentation of clinical study results, medical or scientific literature as well as results from other sources for the use in value dossier and benefit evaluation of medicinal products
5
Experience For Manager, Biostatistics Programming Resume
- Statistical evaluation and review of study documents, regulatory dossiers and other authority generated files
- Presentation of study results with focus on statistical aspects within the Market Access department as well - as required by business need - to other departments
- Professional experience as biostatistician either in the pharmaceutical industry, Biotech or CRO
- Fully acquainted with the practical use of biostatistical software
- At least five (5) years of business experience within the Human Resources function, preferably with experience in the life sciences/healthcare products industry
- Collaborate with various scientists in the design, analysis and reporting of laboratory and early clinical studies (typically through Phase II)
- Frequently interact with regulatory agencies regarding accelerated clinical development options for indications that have substantial unmet medical need
- Worked within a sophisticated, complex corporate environment, as defined by size, geographic presence and/or organizational structure
- Interact with internal and external experts to assure sound quantitative approaches are applied to collection and analysis of a wide variety of data types
6
Experience For Manager, Biostatistics Resume
- Leader to bring innovative statistical thinking and methods to help drive the enhanced quantitative drug discovery and development paradigm within Pfizer. Central to this approach is the systematic review of prior information, statistical model building and simulation, utilizing Bayesian methods as appropriate, to design more effective studies
- Ensure rigorous approaches are taken to ensure good scientific practices are followed: excellent statistical methods utilized and documented in protocols, analysis plans and manuscripts, and assay methods are appropriately blinded, randomized and designed to meet clear objectives
- Use statistical expertise to influence both internal and external reports and presentations, with the aim to improve the quality of internal decision making and increase our influence on the external environment
- Assist in statistical support of assay development, qualification, validation and throughput conducted by the laboratory personnel including the design, development and execution of data collection, analysis and data reports
- Develop effective collaborations with scientist, project management staff, as well as other functional groups to support projects
7
Experience For Senior Manager, Biostatistics Resume
- Assist in Biostatistical input in cross project activities such as staff training programs, working procedures, and various departmental operations and initiatives designed to improve efficiency and productivity
- Experience in multiple myeloma is desired
- Experience in PK/PD analyses is desired
- Responsible for team of statisticians providing Bio statistical input to study design, analysis and reporting
- Satisfactorily completes all cGMP/GLP and safety training in conformance with departmental requirements
8
Experience For Manager Biostatistics Resume
- Where applicable, performs job responsibilities in compliance with cGMP/GLP and all other regulatory agency requirements
- Ensures that Biostatistics Department projects are conducted within budget and in a timely and quality manner
- Prepares and approves research proposals and budgets to provide statistical consulting and to conduct statistical analyses for clients in the pharmaceutical, biotechnology, computer, and manufacturing industries
- Work with cross-functional teams to articulate drug development questions, frame statistical approaches to address those questions, and analyze the resulting data, primarily focused on supporting development strategy and analysis across therapeutic areas covering multiple pipelines within the company
- Take initiative on statistical thinking for all aspects of the exploratory analyses, including identification of the scientific questions, development statistical plans, and interpretation and communication of the results
9
Experience For Senior Manager Biostatistics Resume
- Guided by projects prioritized by the VP of development strategy and analysis, identify and apply novel analysis/modeling techniques for interpreting clinical data and enhancing tools for decision making in development programs that span therapeutic areas, from early clinical to completed phase 3 clinical trials
- Develop and maintain good working relationships with clinical scientists, therapeutic biostatisticians, and external collaborators to drive program strategies and decisions. Proactively seek inputs from other experts within and outside the group on various projects and research activities, and share technical information when appropriate
- Develop innovative statistics methodologies or clinical trial designs for drug discovery, present at management and team meetings, co-author publications and influence the external pharmaceutical industry and regulatory environment through participation in professional associations, conferences, and publications
- Good social skills are essential
- Excellent statistical-methodical knowledge
- Medical writing, Therapeutic Area
- Proactive mindset and hands on approach
- High level of flexibility and responsibility
- Non-clinical & Translational Sciences
10
Experience For Senior Manager, Biostatistics Programming Resume
- Research & External Scientific Innovation
- R&D study/project biostatistician
- Program statistical analyses
- Review and analyze data
- Attend meetings with regulatory agencies
List of Typical Skills For a Manager, Biostatistics Resume
1
Skills For Senior Manager, Biostatistics Resume
- Strong knowledge of clinical trial design, sound understanding of statistical applications for clinical trials
- Experience in contributing to NDAs/BLAs submission
- Demonstrated understanding of drug/device development
- MS, MPH, or PhD in statistics, mathematics, or related field, with 8+ years (MS/MPH) or 4+ years (PhD) experience
- Experience with analysis of pharmacodynamic, safety, efficacy, and biomarker data
- Good knowledge of drug development regulations pertinent to statistical analysis
2
Skills For Manager Biostatistics Resume
- Improve effectiveness of the department with respect to process improvement, systems and sponsor relations with specific focus on Biostatistics
- Demonstrated knowledge of pharmaceutical industry
- Demonstrated knowledge of regulatory process and guidelines
- Experience with statistical models such as Mixed Models for Longitudinal Data and Survival Analysis Techniques
- Review of clinical trial documents as well as validation and quality check of statistical analysis
- Managing biostatistics departmental timelines and resources for clinical studies
- Working knowledge of R, and/or SAS
3
Skills For Senior Manager Biostatistics Resume
- Managing a team of around 10 statisticians in their day to day activities and support their future growth
- Bring innovative statistical thinking and methods to help drive the enhanced quantitative drug discovery and development paradigm within Pfizer
- Researching statistical methodologies
- Develop and manage programming services; manage programming resources and projects for clinical programming activities and deliverables
- Development of statistical part of value dossiers according to GBA-requirements including Medical Writing (Module 4)
- Coordination and monitoring of biometric CRO activities including briefing of Medical Writer in CROs
- Provide input into recruitment process including interviewing
4
Skills For Senior Manager, Biostatistics Programming Resume
- Thorough understanding of the theories and methodologies of conversion, tabulation, analysis, reporting, and integration of clinical data
- Provide programming input into the preparation of marketing applications (NDA/BLA) to FDA, MAA, PMDA or other worldwide regulatory agencies
- Promote quality and productivity through the development, teaching, and proper application of statistical thinking and tools
- Core member of scientific teams responsible for determining strategy and delivering results in a timely and high quality environment
- Capable of conduct research in developing novel methodologies in order to provide support to the dynamic discovery areas
- Knowledge of AMNOG requirements regarding Value dossiers development (e.g. GBA Verfahrensordnung, IQWIG methods)
- Self-organized, structured and motivated to complete projects and achieve goals on time while delivering high quality results
- Proficient in US drug development regulations pertinent to statistical analysis
- Synthesize clinical development and translational research scientific objectives into rigorous analyses
5
Skills For Manager, Biostatistics Programming Resume
- Performs senior technical review and quality assurance of biostatistics’ work products (e.g. Protocols, SAPs, TLFs etc.)
- Provide project related assistance for assigned project(s)
- Meet quality and timeline
- Provide inputs to process improvements
- Understanding of statistical concepts and techniques, such as design of experiments, analysis of variance, linear and nonlinear regression, non-parametric methods, data mining, sample size calculations, variable selection, imputation techniques and high-dimensional data analysis etc
- Demonstrated excellence in statistical skills across multiple areas of pharmaceutical biostatistics, together with broad understanding and experience of the clinical development process
- Ph.D. or equivalent in Statistics, Biostatistics, or related analytical field; with minimal of 6 years of experiences in the device, biopharma, or medical research area in academic and federal organizations Or
- MS in Statistics with two or more years statistical consulting experience in a laboratory science environment or a manufacturing environment
6
Skills For Manager, Biostatistics Resume
- Proven expertise in MS Office Suite including Word, PowerPoint, and Excel
- Keeps abreast of new developments in statistics and regulatory guidance, and publication requirements
- Expert understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses; and be able to efficiently communicate statistical concepts, approaches, or results to internal/external stakeholders
- Strong pre-clinical and non-clinical experience is required
- Experience in the statistical analysis of research collaboration studies
7
Skills For Senior Manager, Biostatistics Resume
- Experience in Statistical Process Control (SPC) and Lean Six Sigma
- Clinical trial experience in either a biotechnology or pharmaceutical company
- Although not required, previous clinical trial experience in the therapeutic areas of Oncology
- Direct experience with a clinical trial submission
- Work in a team environment, including participating and presenting at meetings, including with external representatives
- Provide training and coaching to junior level employees
- Lead meetings with external representatives
- Provide guidance to others on area of expertise in medical affairs team
8
Skills For Manager Biostatistics Resume
- Statistical knowledge through coursework and/or demonstrated statistical application in descriptive and inferential statistics, general linear models, mixed models, and statistical experimental design
- Serve as a core member of scientific teams responsible for determining strategy and delivering results in a timely and high quality manner
- Knowledge in the process and operations of Vaccine products, assay development, reagent qualification, and stability evaluation procedures
- Efficacy, Parallel. Cross-over, Pharmacokinetic and Dose-response studies
- Work with scientists to understand the biology and improve existing biomarkers, endpoints, derive new endpoints, and develop ‘fit-for-purpose’ statistical models
- Use statistical expertise to prepare both internal and external reports, presentations and manuscripts, with the aim to improve the quality of internal decision making and increase our influence on the external environment
- Sound understanding of design of experiments, assay development, and statistical applications for preclinical research
9
Skills For Senior Manager Biostatistics Resume
- Learn new programming languages as required
- Interacts with vendors regarding progress and quality control
- Provide statistical expertise on regulatory submissions and ensure quality of deliverables
- Capability to provide statistical leadership to cross-functional teams
- Expertise in statistical software such as SAS and R is required
- Knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies
10
Skills For Senior Manager, Biostatistics Programming Resume
- Eligible for Relocation Package:: yes
- Eligible for Relocation Package: yes
- Detailed knowledge of statistical regulatory requirements/regulations and currently acceptable statistical methodologies also required
- Instructs CRO on Agensys (Astellas) standards and specifications
- Provides appropriate documents and data
- Ensures that the CRO is updated in case of changes
List of Typical Responsibilities For a Manager, Biostatistics Resume
1
Responsibilities For Senior Manager, Biostatistics Resume
- Provide programming expertise and input to planned and unplanned analyses, including the structure of standard and derived datasets, and the planned documentation of programming activities and TFLs
- Provide strategic guidance and in-depth critical review for the development of Case Report Forms (CRFs) and database designs; ability and experience to guide data management and programming in developing standards for building databases, edit checks, and statistical programming for data analyses
- BS or MS in computer science, statistics, or mathematics
- Responsible for project management of the statistical part incl. timelines and deliverables
- Advise on the methodological aspects and efficiency of clinical trial design
- Registration as Biostatistician or similar (CStat)
- Knowledge of statistical principles, ICH-GCP guidelines and regulation
2
Responsibilities For Manager Biostatistics Resume
- An ability to translate scientific information into business insights
- Provide direct support to key projects transitioning to development including statistical analysis and reports, Review and approve statistical aspects of specific pharmacology reports and other scientific reports. Write statistical summary reports for internal use as well as for submission to regulatory agencies
- Collaborate with internal and external collaborators. Interact with scientists and clinicians, as well as with statisticians at other sites/countries for working group activities
- Participate in training on departmental processes, SOPs, guidelines, and policies. Also organizing training courses, supporting development and implementation of end-user tools
- Provide biostatistical support for clinical trials within the Global Oncology Business Unit
3
Responsibilities For Senior Manager Biostatistics Resume
- Influence the proper use of statistics throughout Eisai’s commercial business; contribute to the development of Biometrics SOPs, standards and guidelines
- Manage biostatistics CRO
- Oversee production of the statistical analyses according to SAP. Oversee preparation of the statistical methods and results sections for CSR and overall summaries. Provide guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package. Serve as company statistical representative at regulatory or external meetings
- Develops and reviews statistical analysis plans, including the definitions of derived variables, the structure and content of analysis data sets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports. Authors technical reports and publications, ensures the timely delivery of top line study results
- Work with the clinical, marketing, project management, and data manager teams on strategic designs of studies; development, review and approval of clinical study protocols; review and approval of CRF, edit check specification, data management plan, and final database validation; author or review and approval of statistical analysis plans and final study report
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