Sr/Pr Statistical Programmer (7+ Years) with R(6 Months)

Trigent Software - Professional Services; India; Vor Ort; INR 1.800.000 - 3.000.000; Vollzeit

Zusammenfassung

Trigent Software - Professional Services in India is seeking a Senior/Principal Statistical Programmer with 7+ years of experience in SAS and R programming to lead end-to-end statistical programming activities for clinical studies.

The role covers SDTM, ADaM, TLFs, regulatory submissions, CDISC standards, and collaboration with cross-functional teams to ensure high-quality deliverables. Mentoring and process improvements are part of the scope.

Qualifikationen

• 7+ years in statistical programming for clinical studies.
• Strong SAS expertise with R experience.
• Good understanding of CDISC standards and trial processes.

Aufgaben

• Develop and validate SDTM, ADaM, and TLFs.
• Create and review programming specifications.
• Support regulatory submissions and ensure CDISC compliance.
• Perform QC and maintain programming standards.
• Collaborate with cross-functional teams and support study deliverables.
• Contribute to process improvements and mentoring activities.

Kenntnisse

SAS programming

R programming

Regulatory submissions

Mentoring

Tools

SAS

R

CDISC SDTM/ADaM

TLFs

Jobbeschreibung

Senior / Principal Statistical Programmer with Minimum (6 Months to 1 Year) of R programming.

Experience

• Senior Statistical Programmer: 7+ years
• Principal Statistical Programmer: 9+ years

Role Summary

Responsible for end-to-end statistical programming activities for clinical studies, from specification creation through regulatory submissions, ensuring high-quality and compliant deliverables.

Key Responsibilities

• Develop and validate SDTM, ADaM, and TLFs.
• Create and review programming specifications.
• Support regulatory submissions and ensure CDISC compliance.
• Perform QC and maintain programming standards.
• Collaborate with cross-functional teams and support study deliverables.
• Contribute to process improvements and mentoring activities.

Required Skills

• Strong SAS programming expertise; Minimum 1 Year of R programming.
• Hands-on experience with SDTM, ADaM, TLFs, and regulatory submissions.
• Good understanding of CDISC standards and clinical trial processes.