DGM, Statistical Programming
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a DGM, Statistical Programming based in India.
This is a senior leadership opportunity for an experienced statistical programming professional to lead complex clinical programming activities across global development programs and regulatory submissions. You will provide technical direction while managing and developing a large team of statistical programmers. The role combines hands-on expertise in SAS, CDISC standards, SDTM, ADaM, and regulatory programming with strategic people and process leadership. You will partner closely with clinical, statistical, regulatory, and external service-provider teams to deliver high-quality outputs on demanding timelines. The position offers significant influence over programming standards, operational processes, and technical best practices. You will also contribute to innovation, department-wide initiatives, training, and the continued development of scalable programming capabilities.
Accountabilities
Lead statistical programming activities across therapeutic areas, compounds, indications, and multiple clinical studies, ensuring high-quality deliverables are completed on schedule.
Manage, mentor, coach, and develop statistical programmers, including supporting new hires and building a strong technical and leadership pipeline.
Provide programming leadership for clinical studies, study reports, regulatory submissions, and ad hoc or post hoc analyses.
Develop and maintain programming documentation, standards, specifications, and processes, including CDISC-compliant SDTM and ADaM mapping and programming specifications.
Develop and oversee SAS programs for SDTM and ADaM datasets as well as Tables, Listings, and Figures (TLFs).
Contribute to the creation and maintenance of standard macros, statistical programming standards, SOPs, training materials, and departmental best practices.
Participate in CRF annotation, SAP reviews, TLF specification development, and TLF quality reviews.
Lead and oversee regulatory submission programming activities, including P21 and eCRT deliverables such as aCRF, Define-XML, cSDRG, ADRG, and ARM.
Support submissions to global health authorities, including FDA, EMA, PMDA, and other regulatory agencies, and help address regulatory requests in collaboration with partner functions.
Work closely with study teams, programming leadership, internal stakeholders, and external functional service providers to define scope, establish timelines, manage dependencies, and ensure successful delivery.
Provide technical expertise and guidance on CDISC standards, regulatory requirements, programming methodologies, and clinical data processes.
Identify opportunities for process improvement and innovation while contributing to departmental goals and cross-functional initiatives.
Promote a culture of excellence, accountability, collaboration, ownership, continuous learning, and high-quality execution.
15-18+ years of statistical programming experience working with clinical trial data in the pharmaceutical, biotechnology, CRO, or healthcare industry.
A minimum bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or a related discipline.
Extensive hands-on experience with SAS programming in a clinical data environment; SAS certification is an advantage.
Demonstrated experience with R and/or Python is preferred and considered an additional strength.
Strong understanding of pharmaceutical clinical development, statistical concepts, clinical trial principles, and regulatory submission processes.
Deep expertise in CDISC standards, including SDTM and ADaM, as well as relevant regulatory guidance and Therapeutic Area User Guides (TAUG).
Significant experience contributing to Statistical Analysis Plans, SDTM and ADaM programming specifications, and TLF development and review.
Strong knowledge of regulatory submission requirements, including NDA, ANDA, eCTD, and related submission deliverables.
Proven experience leading programming activities across multiple studies or projects while managing competing priorities and regulatory timelines.
Demonstrated people-management experience, including hiring, mentoring, coaching, performance development, and building high-performing programming teams.
Strong project and process management capabilities, with the ability to plan workloads, manage timelines, identify risks, and drive delivery independently.
Excellent communication, interpersonal, organizational, and stakeholder-management skills, with confidence working across global and interdisciplinary teams.
A proactive, innovative, and solutions-oriented mindset, with strong analytical and problem-solving abilities.
Ability to balance hands-on technical expertise with strategic leadership and operational management.
Industry connections and experience building or scaling statistical programming teams, particularly within the Indian pharmaceutical or clinical research ecosystem, are advantageous.
Remote or hybrid working options in India.
Opportunity to lead a large statistical programming organization supporting complex global clinical development programs.
Significant exposure to regulatory submissions and collaboration with international cross-functional teams.
Strong opportunities for professional development, technical learning, and leadership growth.
Ability to influence programming standards, processes, SOPs, and innovative ways of working.
Collaborative environment focused on teamwork, accountability, continuous improvement, and professional growth.
Opportunities to contribute to high-impact clinical development and regulatory initiatives.
Comprehensive employee benefits and programs designed to support health, well-being, and financial security.
Career growth opportunities within a rapidly expanding global healthcare and pharmaceutical environment.