Biostatistics Manager
Exelixis•Alameda, CA
•Onsite
About The Position
Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy and marketability of compounds. Projects, prepares the statistical component of protocols which meet project objectives, guidelines and clinical trial methodology standards.
Requirements
- BS/BA degree in related discipline and 7 years of related experience; or, MS/MA degree in related discipline and 5 years of related experience; or, PhD in related discipline and 0 or more years of related experience; or, Equivalent combination of education and experience.
- Typically requires a minimum of 3 years of related experience and/or combination of experience and education/training.
- Expertise with SAS and or R programming is preferred.
- Developed and or reviewed SDTM/ADaM specifications.
- Experience in Oncology or similar related discipline.
- Knowledge of FDA/EMA regulations and guidance documents.
- Problem solving skills, and sound statistical judgment.
- Attention to detail.
- Ability to effectively represent Biostatistics in multidisciplinary meetings.
- Ability to interact effectively with Biostatistical, data management, operations, and clinical personnel from CRO and companies collaborating with Exelixis.
- Uses knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
- Performs a variety of task under only general direction.
- Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
- Has good general knowledge of other related disciplines.
- Applies good analytical and business communication skills.
Responsibilities
- Provide written and verbal recommendations on quantitative/statistical and data management issues.
- Work with project team members on developing clinical protocol.
- Review CRFs, CRF edit checks and CRF completion guidelines.
- Author statistical analysis plan, TLF shells and Table of contents for outputs to be generated.
- Review ADaM specifications and verify primary and secondary efficacy endpoints.
- Assist in performing data analysis, interpretation of study results, and may collaborate with clinical team to produce interim reports, final reports, and publications.
- May interact with and manage counterparts at CROs or companies collaborating with Exelixis.
- Interpret the project implications of regulatory guidelines.
Benefits
- 401k plan with generous company contributions
- group medical, dental and vision coverage
- life and disability insurance
- flexible spending accounts
- discretionary annual bonus program
- opportunity to purchase company stock
- long-term incentives
- 15 accrued vacation days in their first year
- 17 paid holidays including a company-wide winter shutdown in December
- up to 10 sick days throughout the calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Manager
