Job Description
About This Job
Trigent Software - Professional Services
Location: Bengaluru, Karnataka, India
Work Mode: On-site
Industry: Pharmaceutical Manufacturing,Biotechnology Research,Research Services
Job Description
Senior / Principal Statistical Programmer
Experience
Senior Statistical Programmer: 7+ yearsPrincipal 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; R knowledge is a plus.Hands-on experience with SDTM, ADaM, TLFs, and regulatory submissions.Good understanding of CDISC standards and clinical trial processes.
Leadership Requirements
Senior Statistical Programmer: Mandatory co-lead study experience.Principal Statistical Programmer: Mandatory lead study experience.
