Senior Manager, Biostatistics

Responsibilities:
- Partner with Clinical Development, Regulatory, Manufacturing, and Commercial organizations on the design and execution of clinical trials.
- Oversee statistical components of clinical studies by CROs and independent contractors; manage on-time and 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 standards compliance, and submission readiness.
- Stay current with regulatory requirements for statistical methods and developments in clinical trial statistics.
- Consult internal audit on CRO regulatory compliance with statistical SOPs.
- Participate in standards governance and development of Corcept biostatistical SOPs.

Preferred Skills, Qualifications, and Technical Proficiencies:
- Knowledge of global regulatory guidance for statistical methods and submission requirements.
- Proficiency with SAS; 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 delivery of statistical projects by CROs.

Application instructions:
- Applicants must be currently authorized to work in the United States on a full-time basis.