Sr. Manager - Statistical Programming, Central Services
Core
Technical leader overseeing statistical programming activities, integrated dataset development, and regulatory submission support for clinical trials.
Role type
Senior Manager, Statistical Programming (Clinical Trials)
Builds
Integrated datasets (e.g., pooled ADaM), analysis outputs, and electronic submission packages (eCTD) for regulatory authorities.
Domain
Pharmaceutical/Biotech Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Statistical programming, CDISC standards (SDTM, ADaM, Define-XML), SAS programming, Regulatory submission support, Team leadership, Process improvement
Preferred skills
R or Python, Pinnacle 21 (P21), Global Capability Center (GCC) experience
Technologies
SAS, R, Python, Pinnacle 21 (P21), eCTD
Responsibilities
Lead development of integrated datasets and analysis outputs, Ensure timely delivery of programming outputs adhering to regulatory requirements, Collaborate with biostatisticians and data management, Lead preparation and review of electronic submission packages, Support clinical trial transparency activities, Mentor team members and foster capability building
Seniority
Senior Manager, Hands-on technical leadership with team management