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.
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 TechnicalProficiencies: 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 delivery of statistical projects by CROs The pay range that the Company reasonably expects to pay for this position is $215,300 - $253,300; 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.
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