Clinical SAS Programmer

Position Title: Clinical SAS Programmer Location: Remote

Experience: 8+ Years Contract Duration: 24 Months

Job Summary:

We’re looking for an experienced Clinical SAS Programmer to lead statistical programming activities related to the development and maintenance of integrated clinical safety datasets across one or more compounds, indications, or therapeutic areas. The ideal candidate will collaborate with cross-functional teams including Statistics, Data Sciences, Pharmacovigilance, Medical Writing, and Clinical Operations to ensure accuracy, consistency, and regulatory compliance.

Key Responsibilities:

Lead programming efforts for the creation and maintenance of integrated clinical safety datasets.

Develop and validate SDTM , ADaM , and TLF datasets for CSR , ISS , and ISE submissions.

Design and maintain ADaM specifications and SAS programs supporting ISS/ISE programming and regulatory submissions.

Oversee programming deliverables for IB, DSUR, PSUR , and Annual Safety Reports .

Ensure adherence to internal SOPs, department standards, and CDISC data standards .

Conduct quality checks for data consistency, accuracy, and compliance with statistical analysis plans.

Collaborate with statisticians, data managers, and pharmacovigilance teams to support safety and efficacy analysis.

Troubleshoot and optimize SAS code, macros, and utilities for efficiency.

Provide timely responses to data or programming requests with a high sense of ownership.

Support internal process improvements and ensure training compliance.

Required Skills & Experience:

Strong SAS Programming skills , including data manipulation, macro writing, and debugging.

Proven experience in SDTM and ADaM dataset development and validation.

Experience with CDISC standards and regulatory submission requirements (FDA, EMEA).

Hands-on experience supporting IB, DSUR, PSUR, ISS, ISE, and Study CSR deliverables.

Strong understanding of statistical analysis plans and derivation logic.

Excellent communication skills and ability to work collaboratively in cross-functional teams.

Proven ability to manage multiple priorities and deliver high-quality work under deadlines.

Education & Qualifications:

BS or MS in Statistics, Computer Science, or related field.

Minimum 8 years of experience in SAS programming within the pharmaceutical or clinical research industry.

Demonstrated expertise in clinical trial data , regulatory standards , and programming best practices .