Senior Programming Manager
Job Summary
The Senior Programming Manager leads programming activities for complex or multiple clinical trials, ensuring excellence and consistency across deliverables. This role acts as a subject matter expert in CDISC standards, regulatory requirements, and systems innovation to support global programming practices. The position involves providing hands-on leadership and overseeing programming activities to support successful regulatory submissions.
Responsibilities
- Lead programming activities for complex/multiple trials
- Ensure consistency across deliverables
- Drive enterprise standards and CDISC compliance
- Oversee programming for regulatory submissions
Required Skills
- Expert SAS programming
- CDISC SDTM/ADaM proficiency
- 8+ years clinical trial experience
- Oncology submission expertise
Job Details
Responsibilities:
- Provide hands-on leadership for a trial of high complexity or multiple trials.
- Drive consistency across trials.
- Contribute to enterprise standards and/or training; act as CDISC/regulatory SME.
- Support major Standards/Systems/Process capability, shaping proposals for the governance board.
- May oversee all programming activities in support of regulatory submission.
- Act as SME and/or pillar owner in the capability-governance framework.
Experience & Qualifications:
- Bachelor's or Master's degree in statistics, biostatistics, computer science, or a related field.
- 8+ years of relevant experience in pharmaceutical/biotech environments.
- Skilled SAS programmer with strong knowledge of CDISC SDTM/ADaM models, efficient coding practices, and contextual understanding of clinical data.
- Analytical, thorough, and proactive, with the ability to manage multiple tasks independently while maintaining high quality and accountability.
- Collaborative team player with excellent communication, planning, and knowledge-sharing abilities.
- Oncology submission experience preferred.