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 Programmer

- Very strong SAS programming skills

- Very good understanding of clinical trials and clinical data workflows

- Hands-on experience in mapping data to CDISC standards (SDTM and ADaM) and/or OMOP

- Experience creating and maintaining CDISC documentation such as define.xml, reviewers guides, and aCRF

- Experience working with Pinnacle21 for data validation

- Proven experience producing TLFs based on SAPs

Soft Skills :

- Fluency in English with strong verbal and written communication skills

- Strong problem-solving mindset with attention to detail

- Ability to work collaboratively with cross-functional teams

- Fast learner with the ability to adapt to new tools and methodologies

- Strong interpersonal and organizational skills

Additional Skills (Good to Have) :

- Previous experience working with Real World Data (RWD)

- Exposure to pharmacokinetic (PK) calculations

- Experience with R programming