Associate Director of Statistical Programming

Role Summary

Associate Director of Statistical Programming responsible for providing leadership in statistical programming to support clinical development. Oversees vendors and contract programmers to ensure high-quality deliverables and validation of results. Leads programming activities across clinical programs and drives standards, guidance, and processes in line with ICH regulatory requirements. This is a hybrid, office-based role based in Salt Lake City, Utah or New York City, New York, with in-office work at least 50% of the time.

Responsibilities

• Lead statistical programming activities across clinical programs, ensuring development and quality control of tables, listings, figures, analysis datasets; conduct exploratory statistical analyses to support key decision-making.
• Oversee external functional service providers to ensure timely and high-quality programming deliverables.
• Develop and maintain standards, guidance, applications, and processes for Statistical Programming operations in adherence with ICH and regulatory requirements.
• Drive adoption of innovative programming technologies and workflows to enhance the efficiency of clinical data review, cleaning, reconciliation, and integration; develop analytics tools that enable data monitoring and knowledge discovery of clinical data.

Qualifications

• 8+ years of statistics and programming experience with advanced knowledge in pharmaceutical/biotechnology industries, and 5+ years serving as Lead Statistical Programmer across multiple therapeutic areas.
• Proficiency in SAS, R, and R-Shiny; mastery of complex graphing techniques to derive analysis datasets, produce tables, figures and listings, and conduct exploratory analyses.
• Skilled in developing open-source R packages and visual analytics for exploratory and interactive data analysis, visualization, and insight generation.
• Expert knowledge of data standards including CDISC, SDTM, and ADaM, and relevant regulatory guidelines.
• Experience with regulatory submissions in the US, Europe, and other regions.
• Excellent interpersonal and communications skills including ability to manage and resolve conflicts.

Education

• BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree.