Stats Programmer / SDTM Programmer

Innova Solutions; Hyderabad; On-site; INR 2,600,000 - 3,800,000; Full time

Job summary

Innova Solutions seeks an experienced SAS Programmer to develop and validate analysis datasets (ADaM/SDTM) for regulatory submissions. You will lead programming tasks, review SAPs, data plans, and coordinate with vendors to ensure compliant, high-quality GBDS outputs.

Responsibilities include independent programming, process improvements, and supporting e-submission readiness while maintaining strong collaboration with cross-functional teams.

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, relational databases.
• Experience with MS Office, XML, Pinnacle 21.
• Expertise in upstream data handling (eDC, SDTM).
• Experience producing ADaM datasets, Define.xml, submission deliverables.
• Knowledge of regulatory standards, clinical tests, and terminology.
• Strong team collaboration skills.

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

Analytical programming

8+ years clinical programming

CDISC knowledge

Relational databases

Regulatory standards understanding

eDC/SDTM

Define.xml/submission deliverables

Pinnacle 21

XML

MS Office

Education

Bachelor's degree in Statistics, Biostatistics, CS, Mathematics, or Life Sciences

Tools

Pinnacle 21

XML

MS Office

R

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

• Bachelors 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, relational databases.
• Experience with MS Office, XML, Pinnacle 21.
• Expertise in upstream data handling (eDC, SDTM).
• Experience producing ADaM datasets, Define.xml, submission deliverables.
• Knowledge of regulatory standards, clinical tests, and terminology.
• Strong team collaboration skills.

Preferred

• 8+ years of clinical/statistical programming experience.
• Experience supporting regulatory filings (NDA/BLA/MAA).
• Experience with R and Linux OS.