Associate Director, Statistical Programming

About the Role

The Associate Director, Statistical Programming works closely with the Executive Director, Statistical Programming and other members of the Biometrics team to provide programming support across all programs. The ideal candidate will provide hands-on programming and validation support to project teams, oversee external vendors to ensure timely and accurate deliverables, and offer technical expertise to development programming standards and procedures.

Responsibilities

• Provides strategic input regarding the development of statistical programming processes and contribute to maintaining programming-related SOPs, work instructions, and technical standards.
• Assists in the development of programming standards and tools to improve the efficiency and accuracy required to support the analysis and reporting for clinical development projects.
• Leads projects/studies, oversees contractors, and ensures quality and timeliness of programming deliverables.
• Programs analysis datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), DSUR, PSUR, IB, progress reports, electronic submissions, and other internal and external requests (e.g., publications, responses to regulatory questions).
• Reviews/develops CDISC specifications and reviews/generates SDTM data sets, ADaM data sets, and Define.xml files along with all supporting documentation for submissions.
• Provides statistical programming and validation support for clinical study reports, oversees external vendors (e.g., CROs), and coordinates programming activities with Biometrics lead, data managers, and other study programmers.
• Develops and/or reviews SAPs, case report forms, clinical DB specifications, validation plans, TLFs, reporting and analysis datasets specifications, and supporting documentation.
• Provides input on the application of programming methodologies to support the clinical development process.

Requirements

• Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related technical discipline. Master’s preferred. Equivalent combination of education and applicable job experience may be considered.
• Minimum 8 years’ experience in clinical research, ideally as a SAS programmer for phase I-IV clinical trials in a pharmaceutical/CRO environment.
• 3-5 years of progressive leadership experience with at least 3 years’ experience as Lead Programmer.

Skills

• Experience in managing vendors and/or direct reports.
• Technical knowledge and experience with SDTM, ADaM, and Define.XML.
• Strong understanding of the drug development process, submission-related activities, and regulatory requirements (e.g., CDISC, CDASH, eCTD) and guidelines (e.g., ICH, CHMP, FDA, GCP). Submission support with compliance experience.
• Thorough knowledge of SAS functionalities (including ODS, SQL, MACRO, STAT, GRAPH, and ACCESS) and experience with MS Office. Familiarity or experience with R Software is a plus.
• Proven experience with UNIX and Windows operating systems.
• Understanding of the software development life cycle.
• Well-organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
• Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
• Strong interpersonal and organizational skills and excellent verbal and written communication skills.
• Successful record of creating and managing complex project plans, timelines, budgets, and critical paths.

Pay

Compensation based on level and skill, with a target range of $150,000–$195,000.