RCI-BDX-3286 Senior Statistical Programmer (CDISC/SDTM/ADaM/TLF/Base SAS/SAS Macros/Clinical Trial/SAS/STAT) (Pharma/Medical Device)

On site

Must Have

• Base SAS
• Clinical Data Interchange Standards Consortium (CDISC) Standards
• Data Manipulation
• SAS Macros
• SAS/STAT

Nice To Have

• Python
• R

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 Senior Statistical Programmer – Contractor 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 within the scope of the contract.

Required Qualifications

Education & Experience

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

OR

• Master’s degree (or equivalent) in a related field with 3+ years of relevant statistical programming experience
• Demonstrated experience performing statistical programming in a clinical trials environment (pharmaceutical and/or medical device).

Required Technical Skills

• 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).

Required Professional Skills

• 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.

Nice-to-Have Skills

• Prior participation in regulatory submissions or submission-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 contract position and does not include formal people-management responsibilities.
• The contractor is expected to adhere to all applicable quality, compliance, and safety requirements relevant to their work.