Full Job Description
The Associate Director, Statistical Programming will provide strategic and technical leadership for statistical programming activities across one or more therapeutic areas. This role will establish and maintain statistical reporting standards, drive efficient and high quality programming processes, ensure compliance with CDISC and regulatory requirements, and support clinical development planning and execution across multiple indications.
Responsibilities:
• Lead statistical programming activities in a team-based environment while aligning deliverables with business priorities, study objectives, and program timelines.
• Collaborate with cross-functional teams on clinical study planning and execution to ensure accurate, consistent, and timely data reporting. Ensure quality and timeliness of statistical analysis, reporting, and regulatory submission deliverables.
• Demonstrate strong technical expertise to promote best practices related to programming environments, technology, and programming skillsets.
• Establish and maintain efficient resource management and planning in support of business priorities.
• Manage and mentor statistical programming and data analytics team members by providing guidance, training, performance feedback, and technical oversight. Ensure compliance with CDISC standards and regulatory requirements in support of regulatory submission and inspection readiness.
• Manage and collaborate with Contract Research Organizations (CROs), providing oversight of programming activities, ensuring adherence to project timelines and quality expectations.
Basic Requirements:
• Master's degree in Statistics, Mathematics, Computer Science, or a related discipline, with a minimum of 10+ years of SAS programming experience in a pharmaceutical, biotech, or CRO setting; OR Bachelor's degree in Statistics, Mathematics, Computer Science, or a related discipline, with a minimum of 15+ years of SAS programming experience in a pharmaceutical, biotech, or CRO setting.
• Experience across both early and late phase/registrational trials.
• Strong experience with reporting processes, regulatory requirements, and the software development life cycle.
• Expertise in SAS programming.
• Hands-on experience with CDISC standards, including SDTM and ADaM, and programming using raw data from different EDC and eCOA sources.
Additional Preferences:
• Knowledge of R or Python.
• Strong written and verbal communication skills.
• Ability to work effectively in a cross-functional, matrixed environment and proactively influence teams.
• Demonstrated leadership experience, including the ability to collaborate with peers, oversee and guide colleagues, and drive meaningful business impact.
• Intrinsically curious and deeply passionate about the work we do.
• Embrace ambiguity and push for new practices and technologies.
• Adaptive problem solver - turn issues into opportunities and translates ideas into solutions, even when the path isn't clear.
• Leverage technical depth and a growth mindset to make impact; imagine what's possible and pursue it with intention and energy.
• Demonstrate curiosity and drive self-identified innovation, especially in the exploration of artificial intelligence and digital.
Work Location:
• The Associate Director, Statistical Programming is a remote role based in the US, with infrequent (
