Programming Manager, Clinical Programming

Work arrangement: Flexible—work away from office 20%–40% of schedule (single or consecutive days; max 40% within a 60-day period; approved by hiring manager).

Responsibilities:
- Develop/implement Study Data Tabulation Model (SDTM) standards (CDISC and industry compliance) for study/program needs.
- Align SDTM standards with data collection standards by reviewing eCRFs, supporting external data collection standards, and providing SDTM mapping guidance.
- Ensure SDTM datasets meet CDISC and regulatory submission requirements; review submission data packages for quality/integrity.
- Create quality control processes, metrics, and compliance measures.
- Follow SOPs and global agency regulations/guidance.
- Support standard processes and templates.
- Work with Digital Solutions/IT on technology-enabled clinical trial standards, change control, and standards exchange.
- Support GenSense Dashboards by guiding data structure/organization/contents of SDTM databases.
- Perform in-house data consistency checks.
- Contribute to knowledge sharing and cross-functional/global collaboration.
- Maintain regulatory knowledge and stakeholder relationships; represent Clinical Programming in teams/meetings.

Requirements:
- Bachelor’s degree (Statistics, Computer Science, Life Sciences); Master’s preferred.
- 3–5+ years in pharmaceutical industry; global experience.
- Proficient written/spoken English.
- SAS experience.

Competences/skills: SAS programming; analytical/problem-solving; expert CDISC SDTM; program writing/documentation; organized/archiving; proactive/accountable; innovative; team/knowledge sharing; independent/initiative; communication/planning; multitask without quality compromise.

Compensation/benefits (US candidates): Salary band $117,840–$176,760; eligible for discretionary bonuses/LT incentives. 401(k) match, medical/dental/vision, time off, parental leave, wellness/support resources, tuition reimbursement, commuter benefits, Lifestyle Spending Account.