Senior Manager, Clinical & Statistical Programming
Core
Lead clinical and statistical programming for oncology clinical trials, ensuring high-quality regulatory submission packages (SDTM/ADaM) and supporting IND/NDA/BLA submissions.
Role type
Senior Manager, Clinical & Statistical Programming (Individual Contributor)
Builds
Regulatory submission datasets, Tables, Listings, and Figures (TLFs), and statistical programming infrastructure for the Biometrics department.
Domain
Biotechnology / Oncology / Clinical Trials
Required skills
SAS programming, CDISC standards (SDTM/ADaM), regulatory submission package preparation, clinical trial data analysis, project leadership, cross-functional team management, risk mitigation, ICH/FDA/GCP regulations
Preferred skills
R programming, NDA/BLA submission experience, leading early/late-phase trials, immunology/hematology/oncology therapeutic area knowledge, Master's degree
Technologies
SAS, R, EDC systems, CDISC standards
Responsibilities
Perform clinical and statistical programming for full study life cycle; Review protocols, SAP, and EDC deployments; Guide and review CRO outputs for regulatory compliance; Execute programming for IND/NDA/BLA submissions; Provide hands-on SAS support for safety/efficacy analyses; Offer technical oversight to programmers and contractors; Collaborate with biostatisticians and clinical teams; Support audits and regulatory inquiries; Assist in building departmental infrastructure (macros, SOPs).
Seniority
Senior Manager, hands-on IC with leadership
