Associate Director of Statistical Programming

Role Description

This is a full-time role for an Associate Director of Statistical Programming, based in Wexford, PA. The AD will be responsible for developing and maintaining statistical programs, managing and analyzing clinical trial data, and collaborating with cross-functional teams to ensure data quality and integrity. The role involves close coordination with data management, biostatistics, and clinical teams to support regulatory submissions and research initiatives.

While the name of our company remains confidential at this stage, further details will be shared with shortlisted candidates.

Responsibilities:

• Act as a technical authority for programming activities and guide teams on complex data analysis tasks.
• Offer programming-related insights and support to cross-functional partners, including Data Management and Biostatistics.
• Design, build, and validate SDTM-compliant datasets following industry conventions and regulatory expectations.
• Generate ADaM datasets and produce statistical outputs such as listings, summary tables, and visual displays for clinical analyses.
• Oversee work performed by external programming partners to ensure timelines, quality benchmarks, and specifications are met.
• Evaluate and help create annotated CRFs and database structures to support accurate data capture and downstream analyses.
• Coordinate and take ownership of programming tasks across multiple studies or projects.
• Provide guidance, coaching, and onboarding support to less experienced programmers or data-focused colleagues.
• Contribute to the creation, revision, and adherence to internal processes, documentation, and best-practice guidelines.
• Keep current with emerging tools, standards, and techniques in clinical data programming and help introduce improvements where beneficial.
• Define and uphold programming standards across assigned programs to maintain consistency and regulatory compliance.
• Conduct thorough checks of programming outputs prior to internal review or external submission.

Qualifications:

• Bachelor’s degree in a quantitative or scientific discipline is required; an advanced degree (e.g., MS in biostatistics, statistics, or a related area) is advantageous.
• 6 years of hands-on experience working with SAS and clinical study programming in a pharmaceutical, biotechnology, or similar regulated environment.
• Recent direct industry experience required.
• Proven expertise with SAS programming techniques and the ability to apply them to complex clinical datasets.
• Solid understanding of CDISC frameworks, including SDTM, ADaM, and related data standards.
• Direct involvement in developing, validating, executing, maintaining, and documenting clinical datasets and outputs intended for regulatory review.
• Prior contribution to major regulatory submissions (e.g., BLA, MAA) is strongly preferred.
• Familiarity with R or other statistical computing tools is considered a plus.
• Experience coordinating project activities and leading teams or initiatives within a clinical data function.
• Strong working knowledge of clinical research processes, medical concepts, and data standardization practices.
• Background in overseeing or collaborating with external CROs or programming vendors.
• Exceptional communication and collaboration abilities, with comfort operating both independently and within a fast-paced team setting.

Job Type: Full-time

Pay: $125,000.00 - $175,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Paid time off

Work Location: In person

Salary : $125,000 - $175,000