1478# Associate Director, Statistical Programming Permanent Role - Hybrid

ClinChoice•Waltham, MA

13d•Hybrid

About The Position

ClinChoice is currently recruiting for a Associate Director of Statistical programming, Hybrid to join our client’s team in a permanent position—an exciting opportunity to lead impactful statistical strategy in a dynamic environment. This is a Hybrid role, with a preference for candidates who can travel to the client’s location - Waltham, MA. We are seeking an experienced Associate Director of Programming to lead programming activities, build scalable processes, and ensure high-quality deliverables for regulatory submissions. The Associate Director, Programming will serve as a strategic and technical leader within the Biometrics team. This role will oversee clinical programming deliverables across studies, manage internal and external resources, and drive the adoption of modern programming tools and standards. The ideal candidate has strong expertise in SAS and/or R, deep knowledge of CDISC standards, and experience supporting regulatory submissions.

Requirements

Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field.
8–12+ years of experience in clinical programming within pharma/biotech or CRO.
Strong proficiency in SAS, with experience in R being a strong plus.
Expert-level knowledge of CDISC standards (SDTM, ADaM).
Experience managing or overseeing programming teams and external vendors.
Proven track record supporting regulatory submissions (FDA, EMA, PMDA, etc.).
Excellent communication, leadership, and project management skills.

Responsibilities

Lead programming strategy across multiple clinical studies and development programs.
Oversee and manage internal programmers and external vendors/CRO partners.
Establish and maintain programming standards, processes, and best practices.
Support planning, timelines, and resourcing for all programming activities.
Provide oversight and hands-on support for the development and validation of: SDTM, ADaM datasets TLFs (Tables, Listings, Figures) Integrated datasets for ISS/ISE
Ensure all deliverables meet regulatory, statistical, and quality requirements.
Guide the implementation of programming workflows using SAS and/or R.
Drive automation, reproducibility, and process efficiency within the programming team.
Partner closely with Biostatistics, Data Management, Clinical Operations, and Regulatory teams.
Serve as a key programming representative in study team meetings.
Support regulatory submissions, including eCTD-ready deliverables, reviewer guides, and traceability documents.