Manager 2, Statistical Programming in India at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Manager 2, Statistical Programming in India.

This role plays a critical part in global clinical development by leading statistical programming activities across Phase I–IV clinical studies. You will ensure the delivery of high-quality, regulatory-ready datasets, tables, listings, and figures that directly support clinical reporting and submissions. Working in a highly collaborative, global environment, you will partner with cross-functional teams, external vendors, and regulatory stakeholders to ensure consistency, accuracy, and compliance with industry standards. The position involves both hands-on programming and strategic oversight, contributing to the development of standards, tools, and processes. You will also play a key role in mentoring junior programmers and strengthening programming excellence across studies. This is a high-impact role where precision, scientific rigor, and collaboration come together to support global regulatory and clinical outcomes.

In this role, you will lead statistical programming activities across multiple clinical studies, ensuring timely, accurate, and regulatory-compliant deliverables. You will develop datasets, analysis outputs, and documentation aligned with global standards while contributing to process improvements and team capability building.

• Lead statistical programming activities across Phase I–IV clinical studies and therapeutic areas
• Develop SDTM and ADaM datasets, including mapping specifications aligned with CDISC standards
• Program and validate SAS outputs for tables, listings, and figures (TLFs) for clinical reporting
• Contribute to CRF annotation, SAP review, and TLF specification development
• Support regulatory submissions by preparing and managing eCTD-related packages (e.g., define.xml, ADRG, cSDRG)
• Develop and maintain standard macros, libraries, and programming utilities
• Ensure compliance with regulatory guidelines (FDA, EMA, PMDA) and submission requirements
• Mentor junior programmers and support knowledge sharing across teams
• Collaborate with global stakeholders to ensure alignment on timelines, quality, and deliverables

The ideal candidate brings strong statistical programming expertise in clinical development environments, with deep knowledge of regulatory standards and CDISC implementation. You are highly analytical, detail-oriented, and comfortable working in global, cross-functional teams.

• Bachelor’s degree in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or related field
• 4+ years of experience in statistical programming within pharma, biotech, CRO, or healthcare industry
• Strong expertise in SAS programming; knowledge of R or Python is a plus
• Solid understanding of clinical trial processes, statistical concepts, and regulatory submissions (NDA, ANDA, etc.)
• Strong knowledge of CDISC standards (SDTM, ADaM) and regulatory guidance
• Experience preparing regulatory submission packages (e.g., define.xml, ADRG, cSDRG)
• Ability to work independently and within global interdisciplinary teams
• Strong communication, problem-solving, and organizational skills
• Attention to detail with a proactive, ownership-driven mindset
• Mentoring experience with junior team members is a plus

• Competitive compensation package aligned with experience
• Health and wellness benefits supporting physical and mental well-being
• Opportunities for professional development and continuous learning
• Exposure to global clinical development and regulatory programs
• Collaborative, team-oriented work environment
• Career growth opportunities within a global organization
• Flexible/hybrid work arrangement depending on project needs