Associate Director, Programming Statistical Computing Environment

Associate Director – Statistical Computing Environment (SCE)

Responsibilities
- Serve as Business System Owner for the Statistical Computing Environment, maintaining the validated state of the GxP platform in partnership with IT, QA, and vendors.
- Lead business validation lifecycle activities: change impact assessment, UAT, regression testing, and approval of vendor validation documentation.
- Manage and assess vendor-driven system releases/changes, including risk evaluation, documentation updates, communication, and testing prior to deployment.
- Conduct and document periodic system reviews to confirm fitness for intended use, access governance, compliance posture, and vendor performance.
- Participate in deviation management and CAPA for system functionality or compliance.
- Ensure business-level compliance with global regulations and maintain inspection readiness of documentation, processes, and system controls.
- Define and prioritize platform roadmap aligned with clinical and statistical programming strategy.
- Lead operational oversight and end-user support; ensure high service levels and effective issue resolution.
- Lead end-user training and engagement to communicate updates and drive adoption.
- Author and maintain controlled process documentation for system usage, environment management, and user access.
- Partner with IT and QA on supplier qualification, vendor oversight, and review of audit/SOC documentation for the SaaS platform.
- Represent Statistical Programming in cross-functional governance forums.
- Support internal audits and regulatory inspections as the business representative for the SCE.
- Collaborate with IT, Digital Development, and other product owners to enable integrations and interoperability.

Qualifications
- Bachelor’s or Master’s degree in statistics, biostatistics, computer science, or related field and/or 10+ years’ experience in pharma/biotech supporting validated GxP computerized systems.
- Experience as Business/Application System Owner for a GxP platform (preferably SaaS/cloud-hosted).
- Knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, GxP SDLC, change control, and ALCOA+ data integrity.
- Experience reviewing vendor validation documentation and leading UAT/regression testing in a regulated environment.
- Experience supporting inspection readiness, internal audits, and regulatory inspections.
- Practical knowledge of statistical programming environments (e.g., SAS, R) and file/package/workflow management.
- Experience with vendor-based validation models and assessing business impact of SaaS releases.
- Strong analytical/organizational skills; accountable and able to manage competing priorities.
- Bonus: knowledge of open-source package governance and reproducible environment strategies; active participation in PHUSE/CDISC.

Benefits (US, within first year for regular full-time employees)
- 401(k): 100% match on first 6% of contributions; two medical plan options (including HDHP with HSA), dental, vision.
- Voluntary plans: critical illness, accident, hospital indemnity.
- Paid time off: vacation, sick leave, holidays; 12 weeks discretionary paid parental leave.
- Support resources: child/adult backup care, family support programs, financial wellness tools, emotional well-being support.
- Additional perks: commuter benefits, tuition reimbursement, Lifestyle Spending Account.

Salary (US based candidates)
- $164,080.00–$246,120.00; additional compensation may be available (discretionary bonuses, long-term incentives).