Exel
Biostatistics Manager
Alameda, CA
Sponsorship not specified$131k-$186kDetected 31 days ago
RData AnalysisStatisticsFDA RegulatorySASResearchCommunicationCollaborationProblem SolvingBiostatistics
About the role
- Projects, prepares the statistical component of protocols which meet project objectives, guidelines and clinical trial methodology standards.
- Review CRFs, CRF edit checks and CRF completion guidelines.
- Author statistical analysis plan, TLF shells and Table of contents for outputs to be generated.
Responsibilities
- Work with project team members on developing clinical protocol.
- 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.
Requirements
- BS/BA degree in related discipline and 7 years of related experience
- MS/MA degree in related discipline and 5 years of related experience
- It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
Skills
- 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.
- Has good general knowledge of other related disciplines.
- Applies good analytical and business communication skills.
- Works on difficult problems where analysis of situations or data requires a thorough solution.
- Education/Experience:
- BS/BA degree in related discipline and 7 years of related experience; or,
Compensation
- Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets.
This listing is sourced directly from Exel's careers page and normalized into a canonical job model.