PHARMAFull-time
Clinical Data Programmer I (SDTM)
BANGALORE (IN)ONSITEPOSTED: 8/31/2026
PHARMAFull-time
HIRING ORGANIZATIONNOVOTECHBiosciences / Healthcare
ROLE OVERVIEW
Drive clinical submission excellence by transforming raw clinical trial data into standardized SDTM datasets using SAS and Pinnacle 21. Collaborate across biostatistics teams to deliver robust regulatory data packages for global clinical trials.
ROLE DEFINITION & RESPONSIBILITIES
- •Perform SDTM programming and create annotated case report forms (aCRFs)
- •Program and validate clinical datasets from raw operational data to standardized SDTM domains
- •Conduct quality control, double programming, and peer reviews on SDTM deliverables
- •Validate SAS datasets using Pinnacle 21 to ensure regulatory conformance
- •Develop Define.xml files, Study Data Reviewer's Guides (SDRG), and submission packages
- •Document and trace SAS programs according to global standard operating procedures
- •Archive and maintain study files, SAS code, and validation documentation within designated project areas
Reporting Hierarchy: Reports to Manager, Statistical Programming • Team size: 10-15
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor’s Degree in Life Sciences, Computer Science, Mathematics, Statistics, or quantitative field
- 6 months to 2 years of programming experience focused on SDTM concepts
- Proven proficiency in SAS for dataset creation and validation
- Strong working knowledge of CDISC standards, SDTMIG, and Controlled Terminology
- Understanding of clinical trial protocols, laboratory data structures, and AE reporting
PREFERRED QUALIFICATIONS
- •Base SAS or Advanced SAS Professional Certification
- •Hands-on experience using Pinnacle 21 Enterprise or Community
- •Exposure to R programming for clinical data workflows and automation
- •Experience generating Define.xml and Reviewer Guides (cSDRG)
REQUIRED VERIFIED SKILLS
SAS
SDTM
CDISC
SDTMIG
Pinnacle 21
Clinical Trial Data
eCRF Annotation
Data Validation
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: NovoLife flexible benefits framework, flexible working options, paid parental leave, wellness programs, and ongoing professional development.
Industry benchmarks in India for 0-2 years of clinical SAS/SDTM programming range between INR 4,00,000 and INR 7,00,000 per annum depending on CRO scale and technical certifications.
ORGANIZATION CONTEXT & CULTURE
Novotech is a leading global full-service clinical Contract Research Organization (CRO) with 30+ offices across Asia-Pacific, the United States, and Europe, partnering with biotechs and pharma innovators to accelerate clinical therapies.
TEAM SIZE: 1,000-5,000 employees
INDUSTRY: Biosciences / Healthcare
Culture: Novotech fosters an inclusive, award-winning workplace culture centered on ambition, gender equality, trust, and flexibility through its NovoLife program.
EXPECTED CAREER ROADMAP
Progresses from Clinical Data Programmer I to Clinical Data Programmer II, Senior SDTM Programmer, and Lead Statistical Programmer or Programming Project Manager.
APPLICATION ADVISORY
Emphasize hands-on experience with SDTM domain creation (e.g., DM, AE, LB), Pinnacle 21 validation checks, and proficiency in Base/Advanced SAS programming.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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