Associate Director Statistical Programming Jobs

About The Position

Requirements

• Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related quantitative discipline. Bachelor's degree with significant relevant experience will also be considered.
• Sr Manager: 7+ years of statistical programming experience within the biotechnology, pharmaceutical, or CRO industry; Associate Director: 9+ years of experience
• Demonstrated experience serving as a lead programmer supporting clinical development programs and regulatory submissions.
• Advanced proficiency in SAS programming, including Base SAS, Stat, Graph, Macro, SQL, and generation of submission-ready deliverables.
• Extensive experience with CDISC standards, including SDTM, ADaM, Define.xml, controlled terminology, and regulatory submission requirements.
• Strong understanding of ICH guidelines, GCP, FDA, EMA, and other global regulatory requirements.
• Experience managing external CROs, FSPs, or programming vendors.
• Excellent project management, organizational, communication, and stakeholder management skills.

Nice To Haves

• Working knowledge of R or other modern statistical programming languages is a plus.
• Experience with producing publication-quality statistical graphics using SAS/R is a plus
• Experience with building/contributing to global SAS macro library for TFL generation is highly desirable
• Experience with Pinnacle 21 is a plus
• Experience supporting multiple clinical programs from early development through regulatory submission.
• Experience implementing programming standards, automation initiatives, or modern analytics platforms.

Responsibilities

• Lead statistical programming activities for one or more clinical studies, programs, or therapeutic areas.
• Provide strategic oversight and accountability for the development, validation, and delivery of statistical programming outputs, including SDTM and ADaM data packages (SDRG, ADRG, Define.xml, submission-ready datasets), and Tables, Listings, Figures (TLFs).
• Ensure programming deliverables meet quality, timeline, regulatory, and audit-readiness requirements.
• Support regulatory submissions, health authority interactions, publications, and ad hoc analyses.
• Manage and oversee outsourced statistical programming activities conducted by CROs and external partners.
• Review and validate datasets, TLFs, specifications, and programming documentation generated by vendors.
• Monitor vendor performance, timelines, quality metrics, and resource allocation to ensure successful project execution.
• Establish and maintain effective partnerships with external programming and biometrics vendors.
• Partner closely with Biostatistics, Data Management, Clinical Operations, Medical, Medical Affairs, Regulatory Affairs, Pharmacovigilance, and other stakeholders to deliver high-quality clinical data and analyses.
• Review and provide programming input on Protocols, Statistical Analysis Plans (SAPs), Data Management Plans (DMPs), CRFs, annotated CRFs, data review plans, and dataset and TLF specifications.
• Collaborate on the development of data review tools, dashboards, visualizations, and other statistical applications to support clinical development activities.
• Communicate programming strategies, timelines, risks, and resource needs to project teams and leadership.
• Contribute to the development, implementation, and continuous improvement of internal statistical programming standards, processes, and best practices.
• Assist with establishing framework of programming environment, including library of macros.
• Drive adoption of CDISC standards, programming automation, and innovative analytical solutions.
• Maintain expertise in regulatory requirements, industry standards, and emerging technologies related to statistical programming.
• Support inspection readiness and represent Statistical Programming during audits and regulatory inspections as needed.
• Mentor, coach, and develop junior statistical programmers to support individual growth and organizational success.
• Provide leadership and technical guidance to internal and external programming teams.
• Participate in recruiting, onboarding, and developing programming talent.
• Foster an inclusive, collaborative, and psychologically safe environment that encourages innovation, learning, and accountability.