Statistical Programmer

Astek

4 - 14 years

0 Lacs

india

Posted:1 day ago| Platform: Foundit logo

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Skills Required

cdisc standards adam dataset development tlf programming

Work Mode

On-site

Job Type

Full Time

Job Description

Key Responsibilities

Develop, validate, and maintain
ADaM datasets
,
TLFs
, and other analytical outputs for clinical trials.
Support
Oncology studies
by ensuring accuracy, consistency, and regulatory compliance in all programming deliverables.
Contribute to
ISS/ISE activities
, including dataset integration, analysis, and documentation.
Work closely with statisticians, data managers, and clinical teams to ensure timely and quality delivery.
Assist in
regulatory submissions
and
RTQs
, providing clear, traceable, and compliant programming outputs.
Collaborate in an
agile environment
, participating in sprint meetings, planning, and continuous improvement discussions.
Work with internal tools and platforms, including
GSK-specific tools
, following established standards and governance.
Troubleshoot data/programming issues and propose process enhancements.
Ensure adherence to CDISC standards, good programming practices, and audit-ready documentation.

Required Skills & Qualifications

4-14 years of Industrial experience
Proficiency in R programming
(Intermediate candidates with strong learning intent and ability to upskill quickly will also be considered.)
Solid experience in
SAS programming
, especially in a clinical/biostatistics environment.
Hands-on expertise in
ADaM dataset development
and
TLF programming
.
Good understanding of
CDISC standards
and clinical trial data flow.
Strong problem-solving skills, attention to detail, and ability to work in cross-functional teams.

Preferred Qualifications

Advanced or Expert-level R Programming
skills.
Experience working on
Oncology therapeutic area
studies.
Exposure to
ISS/ISE
, submission workflows, and regulatory interactions (e.g., RTQs).
Practical understanding of
agile ways of working
(Scrum/Kanban).
Prior experience using or supporting
GSK tools and platforms
.

Why Join Us

Opportunity to work on impactful
Oncology research
with global teams
Continuous learning and upskilling environment
Collaborative, agile work culture
Exposure to end-to-end statistical programming lifecycle and regulatory submissions

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