Executive Director, Statistical Programming

Position Summary:
The Executive Director, Statistical Programming will lead the Statistical Programming function within the Biometrics Department, identifying project programming demands and resource needs, providing hands-on programming support, leading statistical programmers, and coordinating with external vendors, statisticians, and cross-functional teams to ensure timely and accurate programming and validation for clinical studies.

Responsibilities:
- Serve as head of Statistical Programming within Biometrics.
- Provide strategic input and leadership for statistical programming across clinical development projects.
- Ensure programming deliverables support analysis and reporting for clinical development.
- Deliver statistical programming and validation support for study reports and key outputs: analysis datasets, tables/figures/listings, ISS/ISE, DSUR/PSUR, IB, progress reports, electronic submissions, and regulatory/publication responses.
- Lead/review CRFs, clinical DB specifications, SAP, dataset specifications, validation plans, and TLFs.
- Ensure quality of programming deliverables.
- Develop/maintain programming SOPs, work practice documents, standards, and specifications.
- Ensure scalable, connected, secure Biometrics systems/processes with IT and QA.
- Manage/oversee vendors (CROs/contractors), including qualifications and GCP audits with QA.
- Apply programming methodologies and develop/maintain analysis/reporting applications.
- Train/coaching and manage professional development of programmers.
- Represent Biometrics in cross-departmental process/quality initiatives.

Education/Experience Requirements:
- Bachelor’s degree (Statistics/Computer Science/Mathematics/related); Master’s preferred.
- 14+ years clinical SAS programming (Phase I–IV) in pharma/CRO; 7+ years in leadership/management.

Additional Skills/Experience (required unless noted):
- Leadership and managerial/technical expertise in SAS programming.
- SDTM, ADaM, Define.XML.
- Drug development and submission/regulatory requirements (CDISC/CDASH/eCTD; ICH/CHMP/FDA/GCP).
- Submission support with compliance experience.
- Advanced SAS (ODS, SQL, MACRO, STAT, GRAPH, ACCESS) and MS Office; R is a plus.
- UNIX/Windows proficiency; strong software SDLC knowledge.
- Communication skills; travel ~10%.

Benefits:
- Premium health, financial, work-life/well-being; wellness programs; life insurance; disability; retirement with employer match; generous paid time off.

Application Instructions:
- Accepts applications on an ongoing basis until a candidate is selected.