Overview
Associate Manager, Statistical Programming within Central Services, supporting integrated analysis, regulatory submissions, and clinical trial disclosure activities.
What you'll do
- Create integrated and pooled analysis datasets, reports, and programming documentation using established standards.
- Support preparation and review of electronic data packages for regulatory submissions while ensuring compliance.
- Coordinate with Clinical Transparency and Trial Disclosure teams to deliver datasets and disclosure-required outputs.
- Provide technical expertise to develop tools, standard processes, and programming solutions to improve efficiency and compliance.
- Troubleshoot programming, validation, and submission-related issues, and support implementation of procedures.
- Support inspection readiness and respond to programming-related inquiries during regulatory inspections.
What you'll need
- MS (or BS) degree in Statistics, Computer Science, Mathematics, Engineering, Life Science, or a related discipline.
- 5+ years programming experience with an MS degree or 6+ years with a BS degree (preferably clinical trial data processing).
- Project and people management experience.
- Proven experience supporting regulatory submissions and compliance with global standards, including CDISC, FDA, EMA, and PMDA requirements.
- Proficient SAS programming skills in a clinical data environment (Base SAS, SAS/STAT, Macro, and Graph).
- Strong expertise in CDISC standards (SDTM, ADaM, and Define-XML).
Details
- Location: Hyderabad, India (Hybrid).
Read the full description and apply on the company’s own careers page.
