ADAM+ TLF programmer

Wissen Infotech; Bengaluru; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Wissen Infotech is seeking an experienced SAS programmer to develop analysis datasets (ADaM/SDTM) and TLF outputs for regulatory submissions. You will validate datasets, review SAP/data plans, and coordinate with vendors to ensure compliance and data integrity.

The role requires strong CDISC knowledge, proficiency in SAS, XML, Pinnacle 21, and experience with upstream data handling in eDC/SDTM environments. Collaboration and process improvement are key parts of the job.

Qualifications

• Bachelor's degree in statistics, biostatistics, CS, mathematics, or life sciences.
• Minimum 8 years of programming experience in clinical research.
• Strong analytical programming proficiency.
• In-depth understanding of CDISC and relational databases.
• Experience with MS Office, XML, and Pinnacle 21.
• Expertise in upstream data handling (eDC, SDTM).
• Experience producing ADaM datasets, Define.xml, and submission deliverables.
• Knowledge of regulatory standards, clinical tests, and terminology.

Responsibilities

• Develop SAS programs for analysis datasets (ADaM/SDTM) and TLF outputs.
• Validate analysis datasets and outputs.
• Support e-submission preparation and review.
• Review key planning documents (SAP, data plans) and assess programming impacts.
• Interact with vendors for standards and file transfers.
• Ensure high-quality GBDS deliverables aligned with regulatory standards.
• Identify efficiency and consistency improvements.
• Lead programming assignments independently.
• Support process improvement initiatives.

Skills

SAS programming

CDISC standards

Relational databases

Pinnacle 21

XML

MS Office

R (preferred)

EDC/SDTM data handling

Education

Bachelor's degree in statistics/biostatistics/CS/mathematics/life sciences

Tools

Pinnacle 21

XML

MS Office

Linux OS

Job description

Key Responsibilities

• Develop SAS programs for analysis datasets (ADaM/SDTM) and TLF outputs.


• Validate analysis datasets and outputs.


• Support e-submission preparation and review.


• Review key planning documents (SAP, data plans) and assess programming impacts.


• Interact with vendors for standards and file transfers.


• Ensure high-quality GBDS deliverables aligned with regulatory standards.


• Identify efficiency and consistency improvements.


• Lead programming assignments independently.


• Support process improvement initiatives.

Required Skills

• Bachelor's degree in statistics, biostatistics, CS, mathematics, or life sciences.


• Minimum 8 years of programming experience in clinical research.


• Strong analytical programming proficiency.


• In-depth understanding of CDISC and relational databases.


• Experience with MS Office, XML, and Pinnacle 21.


• Expertise in upstream data handling (eDC, SDTM).


• Experience producing ADaM datasets, Define.xml, and submission deliverables.


• Knowledge of regulatory standards, clinical tests, and terminology.


• Strong team collaboration skills.

Preferred

• 10+ years of clinical/statistical programming experience.


• Experience supporting regulatory filings (NDA/BLA/MAA).


• Experience with R and Linux OS.