Statistical Programmer

Key requirements for the role:

Candidates must have good hands-on experience with ADaM, and TFL programming, covering both safety and efficacy.
Prior experience with R programming will be preferred/an added advantage.

Roles and Responsibilities – Senior Statistical Programmer:

Contribute to or lead statistical programming activities for Phase I to IV clinical trials.
Develop and validate datasets, tables, listings, and figures (TFLs) as per specifications.
Build and maintain effective working relationships with cross-functional teams (biostatistics, data management, clinical teams).
Participate in team meetings and communicate programming progress and issues.
Adhere to company, departmental, and industry standards (CDISC SDTM/ADaM, GCP).
Ensure audit readiness and compliance with regulatory requirements.
Review or develop programming specifications as part of statistical analysis plans.
Participate in or lead the review of eCRFs and data structures.
Ensure accuracy, reliability, and quality of statistical analysis results; perform QC checks on deliverables.
Use SAS and other statistical programming tools (R) effectively.
Mentor and guide junior programmers; contribute to process improvement and standardization initiatives.
Lead programming for studies/project-level activities; coordinate other programmers on the study/project.
Ensure quality and timely deliverables for study-level milestones (DMCs, IAs, Publications, CSRs, submissions, etc.).

Experience/Professional Requirements:

Ideally 7–10 years of experience.
Proven ability to deliver quality outputs and coordinate teams.
Strong knowledge of CDISC and regulatory frameworks.
Good understanding of regulatory requirements (GCP, ICH, etc.).
Excellent communication and collaboration skills.

Job Type: Full-time

Pay: ₹1,200,000.00 - ₹2,500,000.00 per year

Benefits:

• Paid sick time
• Provident Fund

Experience:

• R Programming: 1 year (Required)
• SAS: 7 years (Required)

Location:

• Remote (Required)

Work Location: Remote