Principal Statistical Programmer, Clinical Research

WEP Clinical is expanding its India team and is looking for an experienced Principal Statistical Programmer to provide senior-level statistical programming expertise across global clinical studies and regulatory submissions.

The role offers an opportunity to contribute not only to programming delivery but also to standards, processes, quality, client collaboration and the development of the growing India team.

Key Responsibilities

• Lead statistical programming activities across clinical studies.
• Develop and validate SAS programs, SDTM and ADaM datasets.
• Support regulatory submissions, including define.xml and SDRG deliverables.
• Lead programming QC and validation activities.
• Develop and maintain programming tools, templates, processes and SOPs.
• Partner with clients and cross-functional teams on study deliverables.
• Provide technical guidance and support to programming teams.
• Contribute to audits, proposals and bid-support activities.
• Support continuous improvement of programming standards and processes.

Required Skills

• 10+ years of experience in statistical programming within clinical research.
• Strong expertise in SAS, SDTM and ADaM.
• Strong understanding of clinical trial data and regulatory submissions.
• Experience with define.xml and SDRG.
• Strong programming QC and validation experience.
• Experience developing tools, templates, processes and SOPs.
• Experience in client and cross-functional collaboration.
• Exposure to audits, proposals or bid-support activities is preferred.

Why Join WEP Clinical?

• Work on global clinical studies.
• Direct collaboration with international clients.
• Opportunity to shape processes and ways of working.
• Be part of a growing and developing India team.