Job Details

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds...

ClinChoice is currently recruiting for an 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.
Role Overview

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.

Key Responsibilities
Leadership & Strategy

• 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.

Technical & Delivery

• 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.

Cross-Functional Collaboration

• 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.

Qualification Required:

• 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.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

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