Senior SAS Programmer
Location: [Not specified]
Experience Required: 5+ years (recommended for senior-level role)
Job Type: Full-Time
Job Description:
We are currently seeking a Senior SAS Programmer to join our expanding team. This role demands a highly skilled programmer with expertise in statistical programming for clinical trials. You will be responsible for supporting Table, Listing, and Figure (TFL) generation, as well as SDTM/ADaM dataset development and validation. You will work closely with biostatisticians, data managers, and clinical teams to ensure accuracy and compliance in all deliverables.
Key Responsibilities:
SAS Programming:
Develop and validate standard and ad-hoc SAS macros for clinical reporting.
Provide SAS programming support for TFL generation in line with the Statistical Analysis Plan (SAP).
Prepare programming specifications for efficacy and safety variables.
Data Standards & Validation:
Prepare and validate ADaM datasets and derived datasets according to CDISC standards.
Validate SDTM datasets and associated specifications to ensure data accuracy and regulatory compliance.
Conduct validation of Safety Tables using SAS.
Study Documentation & Review:
Review Case Report Forms (CRF) and annotated CRFs (aCRFs).
Review Statistical Analysis Plans (SAPs) and provide input for statistical programming tasks.
Ensure deliverables are consistent with regulatory expectations, internal quality standards, and timelines.
Compliance:
Complete required training programs and ensure alignment with GCP, ICH, and company SOPs.
Desirable Skills and Experience:
Proficiency in Base SAS, SAS/STAT, SAS/Macro programming.
Recognized subject matter expert in SDTM and ADaM datasets.
Familiarity with CDISC, ICH guidelines, and FDA submission requirements.
Strong attention to detail with excellent documentation practices.
Strong analytical, organizational, and communication skills.
Estimated Salary: ₹10 LPA – ₹18 LPA (depending on experience and expertise)
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