Biostatistician Senior Resume Sample
Jaclyn Rice
308 Otho Stravenue,
San Francisco,
CA
+1 (555) 979 0517
Work Experience
Senior Principal Biostatistician
02/2016
-
PRESENT
San Francisco, CA
- Designs and analyzes oncology clinical trials; hospital and/or large national databases; high dimensional xomics studies.
- Designs and analyzes oncology clinical trials; hospital and/or large national databases
- Collaborates with LCI investigators on development of research grant applications
- As a lead statistical programmer, coordinate statistical programming aspects of trials or other project subtasks
- Provides expert bioinformatic analysis of high dimensional raw data from xomics studies in support of translational research
- Develop plan, and write statistical design, methods, and analysis for research proposals. Oversee quantitative evaluation of the resulting data
- Collaborate independently or as co-investigator with other biomedical investigators and assists in developing objectives, designing sampling and randomization schemes, and data collection procedures to achieve study objectives
Senior.biostatistician
03/2012
-
09/2015
Dallas, TX
- Analyze data in collaboration with statistical faculty beginning with univariate and multivariate analyses such as logistic regression and factor analysis for research studies
- Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.#LI-GZ
- Advise data management staff on database design, validation checks and critical data
- Under supervision, manage project budget and resource requirements. Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies
- Represent biostatistics department on project teams, provide support and guidance on data and statistical-related issues to the teams, attend project team meetings as necessary, and be responsible for the quality, accuracy and timely completion of the assigned tasks
- Prepare specifications for data analyses by outside vendors as required. Assure compliance with the specifications by reviewing the vendors' products
- Ensures team members adhere to the SOPs, guidelines and local working instructions
Biostatistician, Senior
09/2005
-
02/2012
San Francisco, CA
- Acts as a Trial or Project Statistician (TSTAT or PSTAT) for the trial/project. In particular, develops report and programming specifications in a Trial Statistical Analysis Plan (TSAP) and update this document as often as needed
- Assumes responsibility for the coordination of all relevant statistical activities for a Trial, Project or Substance
- In collaboration with the statistical expert group member, maintain expertise in therapeutic area, by keeping abreast of new publications with the purpose of increasing the overall efficiency or effectiveness in the department
- Ph.D. in statistics, biostatistics, or biometry; at least 6 years experience in pharmaceutical clinical trial experience, preferably in the pharmaceutical industry and/or Regulatory Authorities, or M.S. in the above mentioned areas with ten years of similar experience
- Successfully plan and conduct a submission project, including interactions with regulatory authorities on statistical issues
- Challenge methodological issues
- Supervise scientific/technical work
Education
University of Minnesota Rochester
2000 - 2004
Master's Degree in Biostatistics
Professional Skills
- A high computing content is considered to be beneficial; however proven computing skills are most important
- Working knowledge of and significant programming skills in other statistical packages (e.g., Stata, R)
- PhD in Statistics with 3-5+ years of biopharmaceutical experience as an industry expert; or MA in Statistics with 5+ years of biopharmaceutical experience
- Experience and understanding of Drug or Device Development in the regulated environment
- Experience with working in human performance
- Experience with writing papers, briefings, or reports for top management
- Experience and collaboration with cross functional teams to ensure organizational timelines and initiatives are met
How to write Biostatistician Senior Resume
Biostatistician Senior role is responsible for programming, research, software, health, sas, design, training, integration, database, oncology.
To write great resume for biostatistician senior job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Biostatistician Senior Resume
The section contact information is important in your biostatistician senior 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 Biostatistician Senior Resume
The section work experience is an essential part of your biostatistician senior 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 biostatistician senior responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular biostatistician senior position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Biostatistician Senior resume experience can include:
- Excellent interpersonal skills with the ability to interact effectively with people, internally and externally (e.g., Contract Research Organizations, experts, management)
- Strong programming skills in SAS and R
- Significant working experience in BIG health data including Insurance Claims Databases, national health survey data, and/or electronic medical records
- Experience with Python, Perl, C++ or equivalent programming languages
- Solid knowledge of statistical and data processing software, e.g., SAS and/or R
- Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V drug development programs
Education on a Biostatistician Senior Resume
Make sure to make education a priority on your biostatistician senior resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your biostatistician senior 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 Biostatistician Senior Resume
When listing skills on your biostatistician senior 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 biostatistician senior skills:
- Excellent working knowledge of and programming skills in desktop and enterprise versions of SAS and Enterprise SAS SQL
- Statistical programming validation, quality control (QC) in the context of assay development, assay validation and clinical trial data analysis
- Work effectively within a cross-functional team is required
- PhD in Statistics or related discipline with 3+year experience or MS in Statistics or related discipline with 5+ years of experience
- Excellent experience in provision of content, database and statistical consultations to investigators, medical students, staff or government officials
- Experience with Nonclinical, Clinical, or Pharmacology studies
List of Typical Experience For a Biostatistician Senior Resume
1
Experience For Senior Principal Biostatistician Resume
- Collaborate with medical monitors and other study personnel on the creation of clinical development plans and clinical trial designs
- Provide statistically sound experimental design and data analysis inputs to meet project objectives and regulatory requirements
- Develop statistical analysis plans for clinical trials or oversee this work
- Sr. Principal: MS with 8+ yrs or PhD with 6+ yrs of experience as a program lead statistician for early phase programs or pivotal studies in late-stage drug development
- Knowledge of FDA regulations, ICH guidelines, the drug development process
- Sr. Principal: MS with 8+ years or PhD with 6+ years of experience as a program lead statistician for early phase programs or pivotal studies in late-stage drug development
- Manages most statistical aspects of trial/project independently
2
Experience For Biostatistician, Senior Resume
- Collaborates independently with study team
- Responsible for some aspects of the Biostatistics Core best practices
- Independently design, document and prepare analysis data sets for the CHAVI-ID Program as well as prepare reports describing the statistical methodologies used along with the interpretation of the statistical analysis
- Learn and apply new statistical methods to the CHAVI-ID Program as needed
- Collaborate with CHAVI-ID program project leaders and develop analysis plans for new research questions that arise
- Perform data management, analysis data set creation or verification, as well as statistical analysis for the EQAPOL Program
- Provide statistical input and researches potential statistical methodologies with the Biostatistics group for application in DHVI programs
3
Experience For Principal / Senior Principal Biostatistician Resume
- Write efficient and complex programs in SAS and/or R for the creation of analysis data sets as well as statistical analyses. Research and discover new programming techniques to share with the Biostatistics team
- Follow all SOPs and relevant guidelines (e.g., ICH, CLSI) for statistical analyses, programming, and statistical assessment of laboratory performance
- Manage multiple projects and deadlines, as well as provide solid estimates of statistical effort required for a research project. Communicate potential project issues with the lead researcher or Biostatistics team
- Work with lead researchers on study design and the preparation of sample size and power calculations. Provide the lead researcher with final data tables, figures, and listings and interpretation of the results
- Experience with R and SAS programming
- Experience with UNIX/Linux environment
4
Experience For Director, Senior Principal Biostatistician Resume
- Experience with bioinformatics, assay analysis, development and assessment
- Perform bioinformatics analysis of next generation sequencing datasets including transcriptomic and genomic data
- Develop and present research for meetings or conferences as well as write statistical method sections for manuscripts and grant applications
- Ensure mechanisms are in place to maintain flow of appropriate information between disciplines on project team
- Develop and coordinate QC procedures for Biostatistics deliverables, ensuring activities are appropriate for effectively and efficiently delivering quality output within specific project
- Statistical analysis of clinical trial data and related decision making
5
Experience For Senior Associate Biostatistician x Resume
- Provide statistical guidance in development of clinical research program and in design of individual studies as part of multi-disciplinary team; responsible for statistical input to protocol; approves protocol as signatory
- Provide statistical input into design/review of format of CRFs
- Determine documentation requirements for Biostatistics aspects of projects. Give guidance to support business and regulatory requirements including definition of appropriate documentation, storage/communication media, and retention/return of documents at study close-out
- Provide support for special committees, e.g., DMCs, including input/review of charters and ensuring maintenance of appropriate blinding
- Contribute to proposal activities and client presentations
- Five years of postgraduate experience in the application of statistics to clinical trials for employees with a PhD in statistics subject; 8 years of postgraduate experience in the application of statistics to clinical trials for employees with an MA/MS in statistics subject
- Self-motivation and able to motivate others
- SAS proficiency including use of a variety of statistical procedures, e.g., nonparametric analysis, linear and non-linear models, categorical data and survival analysis, SAS Macro language
- A professional approach at all times.Education Required
List of Typical Skills For a Biostatistician Senior Resume
1
Skills For Senior Principal Biostatistician Resume
- Creating and delivering training on statistical concepts
- Overseeing and leading data management and monitoring /SPC review process
- Providing statistical support for Manufacturing and Quality
- Competent in experimental design, statistical modeling and inferential statistics
- Actively seeks to acquire knowledge concerning the use of new/novel statistical techniques and their biometric/ biopharmaceutical applications
- Apply and provide training in extremely advanced and sometimes novel statistical methods
- Expert knowledge of FDA and EMA guidance for drug development
- Pharmaceutical or related industry experience with nonclinical, clinical or pharmacology studies, as appropriate, including experience and understanding of drug or device development in the regulated environment
2
Skills For Biostatistician, Senior Resume
- Expert knowledge of concept of Study Designs, including: group sequential design; interim futility / superiority analysis; multiplicity adjustment; and, conditional power
- Lead production and quality control of randomization, analysis plans, statistical reports, statistical
- Provides mentorship and education for GME programs in the way of lectures related to basic statistical methodology. Conducts brief lectures, workshops and grand rounds as needed to foster understanding of statistical methods in clinical applications
- Keeps abreast of new developments in statistics and regulatory guidance through literature review and attendance at workshops and professional meetings
- Collaborates effectively with members of research teams, maintaining good rapport and cooperative relationships. Approaches conflict in a constructive manner. Helps to identify problems, offer solutions, and participate in their resolution
- Ph.D. in statistics, biostatistics, or biometry; with at least 3-5 years of experience in pharmaceutical industry development and clinical research OR M.S. in the above mentioned areas with >5 years of equivalent industry or academia experience
- Related experience in biotech or diagnostic industry with hands on experience in statistical data analysis of assay development, validation and sample bioanalysis
- Fluency and proven ability to perform statistical analysis, with at least five year experience in SAS (including programming), or R is a requirement. SAS Certification is desired but not necessary with relevant expertise and total years of work experience in biostatistics
- Experience leading the statistical analysis of multiple research projects simultaneously
3
Skills For Principal / Senior Principal Biostatistician Resume
- Experience in other statistical software packages like SPSS, JMP or related software is highly desirable
- Work independently in addressing research requirements is required
- Make judgments regarding the selection of statistical tests to be performed, and how to present data is also required
- Knowledge of a broad range of health and behavioral science research analysis techniques and corresponding analytical abilities
- Knowledge of clinical trials methodology, Design of Experiments (DOE), and experience in data analysis of automation of immunoassays and GLP environment experience is highly desirable
- Experience with anti-drug antibody (ADA) assay cutpoint analysis is highly desirable but not mandatory
- Experience in the development of best practices for a biostatistics core
- Experience with MS Office
- Experience with oncology would be an advantage
4
Skills For Director, Senior Principal Biostatistician Resume
- MA or MS in statistics subject, preferably with a strong medical statistics component. (Alternative academic qualifications are assessed for comparability.)
- Record of publications (as joint author) in statistical analysis of preclinical studies and clinical trials is desirable but not essential
- Knowledge of Microsoft packages; PowerPoint, Excel, Word is also required
- Knowledge of qualitative and quantitative methods and analyses to develop or adapt solutions for the assessment and improvement of the Human Performance Program
- Experience in Disease/Therapeutic Area and/or regulatory activities desirable
- Competitive salary and excellent benefits from Duke University
5
Skills For Senior Associate Biostatistician x Resume
- Solid knowledge of statistical analysis methodologies and experimental design for Phase 3 clinical trials
- Experience with regulatory submissions and support
- Working knowledge of current statistical packages ex. SAS, STATA, R etc
- BSc in a computing, life science, mathematical or statistical subject
- An understanding of the biology of oncology disease and drug discovery programs
- Interacts with external departments and organizations, in planning data acquisition from systems on site, as well as from other institutions
- Gather, assemble, and analyze facts and draw conclusions to produce reliable findings to devise recommended solutions
6
Skills For Senior Research Biostatistician Resume
- Lead research teams, originate new ideas, projects, and methodologies, and execute projects and studies within established financial and time constraints
- Ten years of postgraduate experience in the application of statistics to clinical trials for employees with a PhD in statistics subject; 8 years of postgraduate experience in the application of statistics to clinical trials for employees with an MA/MS in statistics subject
- Demonstrated ability to direct projects
- Knowledge of PC database construction, especially MS Access Database Programming
- Strong communication skills, both the oral and written necessary to interact with state and national counterparts, internal and external senior management, project team members and study participants
- Excellent experience in assisting scientific investigators or government officials with preparation of peer-reviewed publications or public reports, evidenced by applicant co-authored publications or public reports
- Demonstrated ability to direct projects, and mentor junior staff
- SAS proficiency including use of a variety of statistical procedures, e.g., nonparametric analysis, linear and non-linear models, categorical data and survival analysis
- Influences decisions that directly impact the assigned clinical trial and team ability to deliver objectives
7
Skills For Senior Biostatistician, Work From Home Resume
- The DHVI environment offers a unique collaborative opportunity in scientific community
- Collaboration with highly motivated, world class colleagues from around the world
- The chance to participate in research at the highest level
- Exposure to many leaders in the field in genomics, bioinformatics, virology, and immunology
- Knowledge of statistical theory including experimental design, categorical data analysis, analysis of variance (covariance), survival analysis, and non-parametric methods
- Provides consultative services to research investigators and study teams in study feasibility assessment, study design (including sample size, power analysis and randomization), data management, data quality planning, and statistical analysis
- Acts as a resource to administration, medicine, nursing, pharmacy and other health system disciplines interested in conducting investigator-initiated research. Serve as a biostatistical reviewer for the Research Committee
- Prepares and writes statistical methods sections and data analysis reports appropriate for IRB proposals, grant applications, presentations and manuscripts
- Record of publications (as joint author) in clinical trials
8
Skills For Senior / Principal Biostatistician Resume
- Sound knowledge of statistical methodology; ability to critique devised hypotheses and results interpretation
- Develop and implement appropriate studies within the context of the organization’s research program including study design, protocol development, data collection and management, project coordination, and research administration and/or investigator lead epidemiological studies. ‘
- Supervisory, project management and organizational skills
- Principal: MS with 6+ yrs or PhD with 4+ yrs of experience as a study statistician with high independency for complicated studies
- Knowledge and experience to exercise independent judgment and provide oversight to programmers, data managers, and junior statisticians
- Principal: MS with 6+ years or PhD with 4+ years of experience as a study statistician with high independency for complicated studies
- Experience in biological and genetic study
- Experience in the development of best practices for a biostatistics core or equivalent entity
9
Skills For SAS Biostatistician / Senior Biostatistician Resume
- Ensuring quality reputation of Novartis with Health Authorities and other external partners
- High impact by leading the statistical scientific activities: planning, evaluation, risk mitigation, health authority acceptability for trials and indications
- Efficient design, analyses, and reporting leading to quality decisions and submissions, and reduced time and costs for development and registration
- Generate study randomizations and provide inputs on maintaining study blinding
- Perform data management and data review using SAS and/or R for quarterly querying of labs in the CHAVI-ID Program
- Acceptability of clinical study report and documentation by Health Authorities including exploratory trial level deliverables
10
Skills For Senior Biostatistician / Oncology Resume
- Provide leadership to the biometrics team on one or more clinical 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 a design
- Work with medical monitors to develop ad hoc analysis plans and ensure analyses are performed appropriately by programming staff
- Key contributor in project planning
- Handles multiple competing projects and deadlines, and coordinates all the statistical needs of each clinical trial/project
- Performs intermediate and advanced statistical analysis and programming for clinical trials and/or research projects
- Represent the department during audits
- Timely delivery of high quality statistical deliverables to meet the needs of the clinical trial team
- Provide update to management on program progress with focus on biometrics
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