Senior Statistical Programmer

Responsibilities

• Ensure departmental or functional training plans are in place and appropriate.
• Perform vendor qualifications regarding statistical programming functions and manage CRO programming issues and activities to ensure on‑time deliverables within budget.
• Generate, validate, and/or review SDTM domains and ADaM datasets and associated specifications.
• Generate, validate, and/or review tables, figures, and listings to support the statistical analysis of clinical‑trial data for regulatory submissions and publications.
• Generate or perform quality control for SAS programs and other study documents (e.g., presentations and reports).
• Maintain complete and auditable documentation of all programming activities.
• Manage datasets and output across SAS programs, studies, and indications to ensure consistency.
• Provide statistical programming support to supplemental or exploratory analyses for pharmacovigilance, regulatory agencies, or any other internal and external ad‑hoc requests.
• Manage programming, testing, and documentation of SAS global utility programs and tools in accordance with standards and validation procedures.
• Develop and/or maintain departmental procedures and standards.
• Review CRFs, edit‑check specifications, and table, figure, and listing mock‑ups.
• Manage, generate, and/or review acrf.pdf, define.xml, define.pdf, and reviewer’s guide documents.
• Assist in validation of SAS per 21 CFR Part 11.
• Train and mentor new members and programmers; supervise contract programmers as needed.

Requirements

• Bachelor’s degree in Statistics, Mathematics, Computer Science, or a related field (required).
• Minimum of 6 years biotechnology/pharmaceutical/CRO industry experience as a statistical programmer.
• Prior experience overseeing statistical programming contractors (required).
• Compound oversight experience (highly preferred).
• Extensive knowledge of SAS macros (highly preferred), as well as Base SAS, SAS/STAT, SAS/Graph, SAS/SQL, and SAS/ODS.
• Experience working with other languages or software (R, Python, Spotfire) in validated environments (strongly preferred).
• Demonstrated extensive knowledge of industry standards, including ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines.
• eCTD NDA submission experience (must).