Associate Director, Biostatistics

Hybrid role (on-site at least 3 days/week).

Responsibilities:
- Partner with Clinical Development, Regulatory, Manufacturing, and Commercial teams on the design and execution of clinical trials.
- Oversee statistical components of clinical studies executed by CROs/independent contractors; ensure on-time, quality delivery of analyses.
- Collaborate with Statistical Programming to generate statistical analyses for internal/external presentations and validate CRO-generated results.
- Evaluate CDISC electronic data packages for completeness, regulatory standards compliance, and submission readiness.
- Stay current on regulatory requirements for statistical methods and scientific 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.
- SAS proficiency; familiarity with SAS/GRAPH, SAS/MACRO, and R.
- Ability to apply complex statistical methods and interpret results.

Preferred Education and Experience:
- PhD in Statistics, Biostatistics, or Mathematics.
- 5+ 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 authorized to work in the United States on a full-time basis.