Sr. Manager Biostatistics

Location
Menlo Park, CA, United States
Posted
Apr 26, 2021
Ref
1711918075
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Job Description
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.