Associate Director, Statistical Programming
About The Position
The Associate Director, Statistical Programming is accountable for program-specific and cross-study statistical programming activities, including oversight of vendor programming activities. In collaboration with cross-functional stakeholders, this position contributes to process optimization, innovation, and consistency across studies. This position provides technical leadership for statistical programming activities across multiple studies within a program, including oversight of vendor-related activities and implementation of data standards. In collaboration with cross-functional stakeholders, this role provides technical consultation to study teams and supports alignment of statistical programming resources and capabilities to meet organizational priorities. This role assists the Head of Statistical Programming in contributing to departmental strategies and driving the continuous improvement of departmental procedures, training, standards, and automation initiatives. This role is based in Waltham, MA.
Requirements
- Bachelor’s degree required; advanced degree preferred in statistics, biostatistics, computer science, life sciences, or a related field
- Minimum of 10 years of statistical programming experience within the pharmaceutical, biotechnology, including multi-study experience
- Advanced proficiency in SAS required; experience with R, Python preferred.
- Strong knowledge and applied experience with CDISC standards (SDTM, ADaM), regulatory submission requirements, and data standards
- Demonstrated experience supporting or leading regulatory submissions, including eCTD deliverables
- Experience coordinating vendor/FSP statistical programming activities across multiple studies preferred
- Demonstrated leadership and project management skills, including the ability to lead cross-functional initiatives and manage multiple priorities simultaneously
- Strong understanding of the clinical development process and cross-functional collaboration with Biostatistics, Data Management and Clinical Development organizations
- Excellent communication, interpersonal, and stakeholder management skills
- Detail-oriented with strong commitment to quality, compliance, consistency, and operational excellence
- Ability to adapt to changing priorities and contribute to departmental strategy, innovation, and continuous improvement initiatives
Nice To Haves
- experience with R, Python preferred.
- Experience coordinating vendor/FSP statistical programming activities across multiple studies preferred
Responsibilities
- Lead and oversee statistical programming activities across multiple clinical trials and studies, ensuring high-quality deliverables, operational consistency, and adherence to timelines
- Collaborate with biostatisticians, data managers, clinical operations, vendors, and other cross-functional stakeholders to define programming strategies, priorities, and study requirements
- Develop, validate, review, and maintain analysis datasets (CDISC standards), tables, listings, and figures (TLFs) in accordance with regulatory guidelines, internal standards, and submission requirements
- Provide technical leadership and oversight for statistical programming deliverables across studies, including consistency of implementation and standards application.
- Review statistical analysis plans (SAPs) and provide strategic and operational input to support execution feasibility, cross-study consistency, and regulatory readiness
- Perform complex statistical analyses and simulations using SAS and/or R and support advanced analytical and data visualization solutions for clinical trial interpretation and decision-making
- Provide expertise in statistical programming for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD), and oversee submission readiness activities across studies
- Coordinate and oversee vendor/FSP statistical programming activities across studies to ensure quality, compliance, and timely delivery
- Build, maintain, and promote reusable, software-agnostic tools, macros, and automation solutions to improve efficiency, scalability, and standardization
- Contribute to the evolution and implementation of departmental programming standards, processes, validation practices, and innovation initiatives
- Mentor and provide technical guidance to junior programmers and may supervise or lead small programming teams or contractors
- Support resource planning, prioritization, and coordination of programming deliverables across studies and programs
- Stay current with industry trends, best practices, regulatory expectations, and emerging technologies in statistical programming and data analysis
Benefits
- MA Pay Range $175,000—$204,000 USD
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What This Job Offers
Job Type
Full-time
Career Level
Manager
