Senior Manager, Biostatistics
Corcept Therapeutics
August 06, 2026
Remote friendly (Redwood City, CA)
United States
Clinical Research and Development
Responsibilities:
- Partner with Clinical Development, Regulatory, Manufacturing, and Commercial organizations on the design and execution of clinical trials.
- Oversee execution of statistical components of clinical studies by CROs/independent contractors; manage on-time, quality delivery of CRO-generated analyses.
- Partner with Statistical Programming to generate statistical analyses for internal/external presentations and validate CRO-generated analyses.
- Evaluate CDISC electronic data packages for completeness, regulatory compliance, and submission readiness.
- Stay current on regulatory requirements for statistical methods and developments in statistical methods for clinical trials.
- Consult Internal Audit on regulatory compliance of CROs with respect to statistical SOPs.
- Participate in standards governance and development of Corcept Biostatistical SOPs.
Preferred Skills, Qualifications, and Technical Proficiencies:
- Knowledge of global regulatory guidance on statistical methods and global submission requirements.
- Proficiency in SAS statistical programming; familiarity with SAS/GRAPH, SAS/MACRO, and R.
- Ability to apply complex statistical methods and interpret results.
Preferred Education and Experience:
- MS or Ph.D. in Statistics, Biostatistics, or Mathematics.
- 2+ years of experience in clinical trial development.
- Demonstrated project management ability in clinical development.
- Experience managing CRO delivery of statistical projects.
Application instructions:
- Applicants must be currently authorized to work in the United States on a full-time basis.
- Partner with Clinical Development, Regulatory, Manufacturing, and Commercial organizations on the design and execution of clinical trials.
- Oversee execution of statistical components of clinical studies by CROs/independent contractors; manage on-time, quality delivery of CRO-generated analyses.
- Partner with Statistical Programming to generate statistical analyses for internal/external presentations and validate CRO-generated analyses.
- Evaluate CDISC electronic data packages for completeness, regulatory compliance, and submission readiness.
- Stay current on regulatory requirements for statistical methods and developments in statistical methods for clinical trials.
- Consult Internal Audit on regulatory compliance of CROs with respect to statistical SOPs.
- Participate in standards governance and development of Corcept Biostatistical SOPs.
Preferred Skills, Qualifications, and Technical Proficiencies:
- Knowledge of global regulatory guidance on statistical methods and global submission requirements.
- Proficiency in SAS statistical programming; familiarity with SAS/GRAPH, SAS/MACRO, and R.
- Ability to apply complex statistical methods and interpret results.
Preferred Education and Experience:
- MS or Ph.D. in Statistics, Biostatistics, or Mathematics.
- 2+ years of experience in clinical trial development.
- Demonstrated project management ability in clinical development.
- Experience managing CRO delivery of statistical projects.
Application instructions:
- Applicants must be currently authorized to work in the United States on a full-time basis.