The Associate Director of 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 is a hybrid role typically requiring on-site presence at least 3 days per week.
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 generation of statistical analyses for internal and external presentations, and validation 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 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:
- 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 delivery of statistical projects by CROs
The pay range that the Company reasonably expects to pay for this headquarters-based position is $183,500 - $269,800; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.