Sr. Manager Biostatistics

Location
Menlo Park, California
Posted
Jun 08, 2021
Ref
946
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

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 design and execution of clinical trials in Corcept portfolio.
  • 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 evaluation CDISC electronic data packages for completeness, regulatory standards compliance and submission readiness.
  • 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.
  • 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 Education and Experience
  • PhD 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 CRO
  • Demonstrated ability to apply complex statistical methods, conduct and interpret the results
Skills, Qualifications or 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.
  • Familiarity with CDISC SDTM and ADaM specifications and associated regulatory guidance
  • Excellent analytical, communication and organizational skills

Position Location – Must be located in the North California/Bay Area.  Out of state applications will only be considered if you have indicated that you are willing to relocate to the Northern California/Bay Area.