Senior Manager / Associate Director Biostatistics

The Senior Manager / Associate Director Biostatistics will be responsible for leading the execution of statistical components of Corcept Development programs. This position will manage external statisticians and statistical programmers. This position can be hybrid (Bay Area) or remote (West Coast hours).

Responsibilities:

• Partner with Clinical Development, Regulatory, Manufacturing, and Commercial organizations on the design and execution of clinical trials in the Corcept portfolio.
• Oversee execution of the statistical components of clinical studies by CROs and independent contractors. Manage on-time and quality delivery of CRO-generated analyses results.
• Partner with Statistical Programming in the generation of statistical analyses for internal and external presentations, and validation of statistical analyses results generated by CROs.
• Partner with Statistical Programming in the evaluation of CDISC electronic data packages for completeness, regulatory standards compliance, and submission readiness.
• Stay current with regulatory requirements for statistical methods of analyses and scientific developments in statistical methods for clinical trials.
• Consult the internal audit team in assessing 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 for analyses of clinical data, and global submission requirements
• Proficiency with statistical programming in SAS. Familiarity with SAS/GRAPH, SAS/MACRO, and R.
• Demonstrated ability to apply complex statistical methods, conduct and interpret the results

Preferred Education and Experience:

• Ph.D. in Statistics, Biostatistics, or Mathematics
• 5+ years of experience in clinical trial development
• Demonstrated ability for project management of projects in clinical development
• Experience managing the delivery of statistical projects by CROs

The pay range that the Company reasonably expects to pay for this position is $185,000 - $243,700; the pay ultimately offered may vary based on legitimate considerations, including job-related knowledge, skills, experience, and education.  An annual cash bonus and equity grants may be provided as part of the overall compensation package, in addition to a full range of medical, financial, and other wellness benefits, dependent on the position offered. 

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

If you are based in California, we encourage you to read this important information for California residents linked here.

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