Principal Statistical Programmer

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Job Description

Role Purpose

Provide hands‑on statistical programming support for clinical studies, including development and validation of analysis datasets and statistical outputs, in accordance with regulatory and company standards. The Principal Statistical Programmer is expected to work independently, deliver high‑quality programming deliverables, and collaborate effectively with Biostatistics and Clinical Data Management.

Key Responsibilities

Primary Responsibilities

• Develop complex analysis datasets, specifications, and summary outputs (tables, listings, figures, and graphs) for inclusion in clinical study reports, regulatory submissions, and internal presentations.

• Create, modify, and maintain SAS programs that meet regulatory and company standards to ensure efficient programming, reporting, review, and traceability.

• Perform independent program review and validation, ensuring complete, accurate, and inspection‑ready documentation in compliance with applicable regulations and internal procedures.

• Support ad hoc and planned analyses in collaboration with the designated statistician, including responses to data review questions.

• Partner with Clinical Data Management and Biostatistics to review CRFs, database specifications, edit checks, and data derivations as needed.

• Proactively identify programming risks, data issues, or efficiency opportunities and communicate them clearly to study team members.

Scope & Level of Independence

• Works independently with minimal supervision, receiving high‑level objectives and delivering agreed‑upon outputs.

• Evaluates alternative programming approaches and applies sound judgment in accordance with regulatory and quality standards.

• May provide technical guidance or support to other programmers, as appropriate.

• Responsible for managing assigned programming tasks and timelines.

Required Skills/

Experience:

• Bachelor’s degree in Statistics, Mathematics, Computer Science, or a related field or other STEM Field with 5+ years of relevant statistical programming experience OR

• Master’s degree (or equivalent) in a related STEM field with 3+ years of relevant statistical programming experience

• Demonstrated experience performing statistical programming in a clinical trials environment (pharmaceutical and/or medical device).

• Strong hands‑on experience with SAS programming for clinical trial data including SAS Base, SAS/STAT, and SAS Macros.

• Proven experience developing and validating:

• Analysis datasets

• Tables, listings, and figures

• Solid understanding of regulatory requirements and guidelines applicable to clinical research (e.g., GCP, ICH, FDA, ISO).

• Experience with CDISC standards (e.g., SDTM, ADaM).

• Experience supporting programming deliverables that are inspection‑ready.

• Proficiency interfacing SAS outputs with common productivity tools (e.g., Microsoft Excel, Word, PowerPoint).

• Strong analytical, problem‑solving, and organizational skills.

• High attention to detail and commitment to data quality.

• Clear written and verbal communication skills.

• Ability to collaborate effectively with cross‑functional stakeholders, including statisticians and data managers.

• Ability to manage competing priorities in a fast‑paced project environment.

Preferred Skills/Experience

• Prior participation in regulatory submissions or submissions‑related deliverables.

• Experience reviewing or validating programming deliverables from CROs or vendors.

• Development of SAS macros or tools that improve programming efficiency.

• Ability to program in other statistical languages such as R or Python.

Additional Information

• This role is an individual contributor position and does not include formal people‑management responsibilities.

• The programmer is expected to adhere to all applicable quality,…