Statistical Programmer

Clinical SAS Programmer

Position: Clinical SAS Programmer

Experience: 5+ Years

Location: Mumbai/Pune/Bangalore/Noida

Salary: Up to 35 LPA

Employment Type: Full-time

Key Responsibilities :

• Develop and validate SDTM, ADaM, and TFLs using Base SAS and SAS Macros.
• Perform statistical programming activities in compliance with CDISC standards.
• Create and maintain Tables, Listings, and Figures (TFLs) based on Statistical Analysis Plans (SAPs).
• Review protocols, Annotated CRFs, and specifications to develop submission-ready datasets.
• Perform QC and validation of SAS programs and datasets.
• Support regulatory submissions for global clinical studies.
• Collaborate with Biostatistics, Clinical Data Management, and cross-functional teams.

Required Skills :

• Strong experience in Base SAS, SAS Macros, and SQL.
• Hands-on experience with SDTM, ADaM, CDISC, TFL Programming, and Define.xml.
• Good understanding of FDA/ICH regulatory guidelines.
• Experience working on Phase I–IV clinical studies.
• Excellent analytical, problem-solving, and communication skills.

Preferred

• Experience across therapeutic areas such as Oncology, Diabetes, Cardiovascular, or Immunology.
• Exposure to Pinnacle 21 and submission support will be an added advantage.

Interested candidates can share their updated resume at: [email protected] & [email protected]