Senior Statistical Programmer

Sun Pharmaceuticals - Princeton, NJ

Full-time - Mid Level

Princeton, NJ

About the position

The Senior Statistical Programmer at Sun Pharmaceuticals will lead programming activities for Phase I-IV clinical studies, ensuring high-quality deliverables and adherence to project standards. This role involves collaboration with internal teams and external partners to support clinical studies, regulatory submissions, and ad hoc analyses. The programmer will also contribute to the development of standard macros and processes, while mentoring junior staff.

Responsibilities

• Lead statistical programming activities for multiple studies/projects in various therapeutic areas.
• Develop and maintain programming documentation following standards and processes.
• Create CDISC standard SDTM mapping specifications and ADaM specifications.
• Develop and oversee SAS programs for SDTM and ADaM datasets and reports.
• Contribute to the development of standard and utility macros and maintain programming standards.
• Participate in CRF annotation, SAP review, and TLF specifications development.
• Handle P21 related items and eCRT package for regulatory submissions.
• Support global regulatory authority submissions and address health authority requests.
• Demonstrate company values through excellence, collaboration, and accountability.
• Plan and complete deliveries and timelines with the study team and management.
• Perform end-to-end programming activities and act as a team player and SME.
• Mentor and coach new hires and junior programmers.

Requirements

• Minimum Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline.
• 4+ years of programming experience in processing clinical trial data in the biotechnology, pharmaceutical, CRO or health care related industry.

Nice-to-haves

• Strong SAS programming skills in a clinical data environment.
• Working knowledge of other programming languages such as R, Python.
• Knowledge of pharmaceutical clinical development and regulatory submissions.
• Extensive knowledge of CDISC standards and regulatory guidance.
• Prior PTL experience and attention to detail.

Benefits

• Health insurance
• 401k plan
• Paid holidays
• Professional development opportunities