Description :
Job Title : Statistical Programmer / R Programmer
Experience : 3-5 Years
Location : Bangalore
Role Overview :
We are looking for an experienced Statistical Programmer / R Programmer with strong SAS programming expertise and a solid understanding of clinical trial data.
The role involves working on clinical and real-world datasets, supporting regulatory-compliant data standards, and producing high-quality statistical outputs in alignment with study protocols and Statistical Analysis Plans (SAPs).
Key Responsibilities :
- Perform statistical programming activities for clinical studies with a strong focus on SAS programming
- Develop, validate, and maintain datasets in compliance with CDISC standards, including SDTM and ADaM
- Map and transform raw clinical data into standardized formats such as CDISC (SDTM / ADaM) and / or OMOP
- Prepare and maintain CDISC-compliant documentation, including define.xml, reviewers guides, and annotated CRFs (aCRF)
- Perform data validation and compliance checks using Pinnacle21 and resolve identified issues
- Produce Tables, Listings, and Figures (TLFs) in accordance with approved Statistical Analysis Plans (SAPs)
- Ensure accuracy, consistency, and traceability of datasets and outputs throughout the study lifecycle
- Collaborate with biostatistics, clinical, and cross-functional teams to support analysis and reporting needs
Required Skills & Experience :
3 to 5 years of experience as a Statistical ProgrammerVery strong SAS programming skillsVery good understanding of clinical trials and clinical data workflowsHands-on experience in mapping data to CDISC standards (SDTM and ADaM) and / or OMOPExperience creating and maintaining CDISC documentation such as define.xml, reviewers guides, and aCRFExperience working with Pinnacle21 for data validationProven experience producing TLFs based on SAPsSoft Skills :
Fluency in English with strong verbal and written communication skillsStrong problem-solving mindset with attention to detailAbility to work collaboratively with cross-functional teamsFast learner with the ability to adapt to new tools and methodologiesStrong interpersonal and organizational skillsAdditional Skills (Good to Have) :
Previous experience working with Real World Data (RWD)Exposure to pharmacokinetic (PK) calculationsExperience with R programming(ref : hirist.tech)