Exel
Associate Biostatistics Director
Alameda, CA · Director
Sponsorship not specified$167k-$237kDetected 31 days ago
Data AnalysisStatisticsClinical TrialsSASCommunicationBiostatistics
About the role
- Works collaboratively with clinicians, data managers, biostatisticians, statistical programmers, and medical writers in the planning, conduct and analysis of clinical trials.
- 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.
- Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications.
- Effectively manage CRO to ensure high-quality deliverables within timeline and budget.
Requirements
- MS/MA degree in related discipline and a minimum of 9 years of related experience
- PhD in related discipline and a minimum of 5 years of related experience
Nice to have
- Experience in oncology and study Phases I-III highly preferred.
- Experience in Biotech/Pharmaceutical industry preferred.
- Experience with managing CROs in the conduct of clinical trials.
- Experience with statistical applications and clinical data management procedures in the conduct of clinical trials.
- Ability to effectively represent Biostatistics and Clinical Data Management in multidisciplinary meetings.
Skills
- Developed/reviewed SDTM/ADaM specifications
- Strong SAS programming knowledge.
- Guides the successful completion of major programs, projects and/or functions.
- Develops technical and/or business solutions to complex problems.
- Has complete understanding and wide application of technical principles, theories, concepts, and techniques.
- Has good general knowledge of other related disciplines.
- Applies strong analytical and business communication skills.
- Education/Experience:
- MS/MA degree in related discipline and a minimum of 9 years of related experience; or,
- PhD in related discipline and a minimum of 5 years of related experience; or,
- Equivalent combination of education and experience.
- May require certification in assigned area.
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.