Research Triangle Park, North Carolina, United States
Ph.d. or m.s. in statistics
10+ years pharmaceutical r&d experience
Sas and/or r programming expertise
The role provides technical leadership for the development of clinical strategies and oversees the design and implementation of non-clinical, CMC, and clinical development programs
Job Summary
The role provides technical leadership for the development of clinical strategies and oversees the design and implementation of non-clinical, CMC, and clinical development programs.
Candidates will serve as the statistical representative in interactions with global health authorities like the FDA and EMA to defend company positions on drug approvals.
This position requires managing external statisticians and CROs while ensuring high-quality, timely deliverables for regulatory submissions including IND and BLA filings.
Matching Summary
The role provides technical leadership for the development of clinical strategies and oversees the design and implementation of non-clinical, CMC, and clinical development programs.
Skills & Requirements
Must-have
Ph.D. or M.S. in Statistics
10+ years pharmaceutical R&D experience
SAS and/or R programming expertise
FDA/EMA regulatory interaction experience
New Drug Application submission knowledge
Nice-to-have
Experience with adaptive and Bayesian study designs
Background in rare diseases and gene therapy
Knowledge of Heart Failure and Cardiovascular programs
CRO selection and contract management skills
Strong cross-functional collaboration abilities
Key Requirements
Ph.D. or M.S. degree in Statistics
Minimum 10 years of pharmaceutical R&D experience
Extensive experience with SAS and/or R
Proven track record in New Drug Application preparation
Leadership experience managing statisticians and data managers