Senior Director, Statistical Programming

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 a Senior Director, Statistical Programming to join our team in a permanent position—an exciting opportunity to lead impactful statistical strategy in a dynamic environment.

Job Summary:

The Senior Director of Statistical Programming will provide strategic leadership and oversight for all statistical programming activities across clinical development programs. This role is responsible for driving programming excellence, ensuring high-quality deliverables, and leading a global team to support regulatory submissions and clinical trial reporting.

Key Responsibilities:

• Provide strategic direction and leadership for Statistical Programming across multiple therapeutic areas

• Oversee the delivery of high-quality programming outputs including SDTM, ADaM, and TLFs

• Ensure compliance with regulatory standards such as CDISC, FDA, and ICH guidelines

• Collaborate cross-functionally with Biostatistics, Data Management, Clinical Operations, and Regulatory teams

• Lead and mentor a global team of programmers, including resource planning and performance management

• Drive process improvements, innovation, and adoption of new technologies/tools

• Support regulatory submissions (NDA, BLA, MAA) and respond to health authority queries

• Establish and maintain SOPs, standards, and best practices

• Manage vendor relationships and oversee outsourced programming activities

• Ensure timelines, budgets, and quality expectations are consistently met

Qualifications:

• Master’s or PhD in Statistics, Biostatistics, Computer Science, or related field

• 12–18+ years of experience in Statistical Programming within the pharmaceutical/CRO industry

• Strong expertise in SAS programming, CDISC standards (SDTM, ADaM), and regulatory submissions

• Proven leadership experience managing large, global teams

• Deep understanding of clinical trial processes and data standards

• Experience interacting with regulatory authorities is highly preferred

• Excellent communication, stakeholder management, and leadership 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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