Associate Director, Statistical Programming

Program Lead Statistical Programmer

Serves as the Program Lead Statistical Programmer on one or more clinical programs and provides statistical programming leadership and strategic input to plans and objectives for the area of responsibility. Brings strong technical expertise across clinical development, with an emphasis on building efficient, fit-for-purpose approaches for early-phase studies where precedent may be limited and study designs or data may require tailored solutions.

Provides expert guidance on analysis, reporting, regulatory submission deliverables, programming processes, tools, standards, and procedures. Partners cross-functionally to strengthen programming practices, support effective progression of programs from early development into later-stage studies, and ensure high-quality, scalable delivery. May have direct reports.

• Provides strategic and technical leadership for statistical programming across one or more clinical programs, helping establish effective ways of working, clear expectations, and scalable practices that support the broader organization.
• Serves as the clinical program lead statistical programmer on one or more clinical programs and supports studies across the development lifecycle, including early-phase and proof-of-concept work.
• Develops and implements efficient, fit-for-purpose approaches for analysis, reporting, and regulatory submission deliverables, including annotated CRFs, dataset transport files, define documents, and regulatory reviewer guides that appropriately address study-specific considerations.
• Creates clear frameworks for programming strategy, resourcing, analysis, and delivery, and identifies opportunities to improve processes and technology to enable consistent, scalable execution across the portfolio.
• Builds and shares expertise in specialized clinical data and study considerations, which may include PK/PD, biomarkers, local and specialty laboratories, healthy volunteers, patients, age groups, and other special populations.
• Provides strong technical statistical programming leadership to the Statistical Programming function within Biometrics and acts as a technical resource and thought partner for statistical programmers and cross-functional stakeholders.
• Plays a lead role in the development and implementation of programming standards and conventions and contributes to building statistical programming infrastructure that supports quality, consistency, and efficient delivery.
• Continually assesses statistical programming workload and project requirements to ensure appropriate programming resources are available to meet project timelines and business priorities.
• Plays a lead role in hiring, training, coaching, and oversight of in-house and contract statistical programmers supporting the analysis and reporting of clinical and nonclinical data for corporate development programs.
• Contributes to the assessment of department software needs and identifies opportunities to use tools and technology to improve the scalability, consistency, and efficiency of statistical programming processes.
• Contributes to the identification and selection of external vendors that provide specialized services to support the statistical programming function and oversees and validates vendor programming activities, including CDISC implementation, analysis reporting, and programming conventions.
• Plays a lead role in the creation and validation of e-submission requirements, ensuring deliverables are compliant, clear, high quality, and appropriately tailored to the study and regulatory context.
• Serves as primary/lead programmer for agency reporting deliverables such as DSUR/Annual Report and IB updates and performs the function of lead and/or quality control statistical programmer on projects as needed.
• Performs other duties as assigned.

• BS/BA degree in a computer science, mathematics, statistics, or related field AND 10+ years of experience in the biopharmaceutical (or CRO) industry as a statistical programmer with advanced knowledge of SAS, (Base, Stat, Macro, graph) required. Experience serving in a managerial role. Experience in the hiring, development, evaluation and support of junior staff and contractors OR
• Master's degree in a computer science, mathematics, statistics, or related field AND 8+ years of similar experience noted above OR
• PhD in a computer science, mathematics, statistics, or related field AND 6+ years of similar experience noted above OR
• Previous managerial / functional management experience also required
• Recognized as an internal thought leader with strong technical and business expertise within a strategic organization.
• Requires broad understanding of the processes, procedures and systems used to accomplish the team's work and familiarity with the underlying concepts in other disciplines within the function.
• Applies in-depth understanding of how own discipline integrates within the function and understands contribution…