DGM, Statistical Programming (Gurugram)

SUN PHARMA; India; On-site; INR 3,500,000 - 5,500,000; Full time

Job summary

Sun Pharma is seeking an Associate Director/DGM of Statistical Programming to lead a large team and drive programming activities for complex studies and regulatory submissions. The role requires setting standards, ensuring high-quality deliverables, and collaborating with internal and external partners in a dynamic, GMP‑compliant environment.

The incumbent will guide CDISC SDTM/ADaM development, oversee SAS programming, and contribute to SOPs and macros while maintaining strong regulatory

Qualifications

• Lead and support all programming activities for complex studies and regulatory submissions.
• Manage a large team of programmers and mentor junior staff.
• Develop and maintain programming standards, macros, and SME topics.

Responsibilities

• Lead statistical programming activities for multiple studies/projects.
• Develop CDISC SDTM mappings and ADaM specifications.
• Create SAS programs for SDTM/ADaM datasets and associated reports.
• Contribute to standard macros and programming standards.
• Review SAP, TLF specifications, and annotation of CRFs.
• Handle P21 related items and eCRT pac.

Skills

SAS programming

CDISC SDTM/ADaM

Team leadership

Regulatory submissions

Education

Master's degree in Biostatistics or related field

Tools

SAS

Job description

JOB DESCRIPTION : The Associate Director/DGM, Statistical Programming will play a pivotal role in providing comprehensive programming expertise to lead and support all programming activities as per the project strategies along with managing a large team of programmers in successful and timely completion of all programming activities for highly complex studies and regulatory submissions. The incumbent should be able to work independently implementing and executing the programming and project standards to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis. The incumbent will work closely with internal partnering functions, stakeholders, and external functional service providers to ensure all the programming deliverables are delivered in timely manner with high quality. The incumbent will participate in and contribute to department goals, SOPs, macros, SME topics and act as a technical expertise to provide guidelines on CDISC standards.

In this role, a typical day might include the following:

• Manage direct reports, Mentor and Coach recent hires and junior programmers.
• Lead statistical programming activities for a therapeutic area or compound/indication within multiple studies/projects in various study activities to ensure timely and high-quality programming deliverables in assigned projects and areas.
• Develop and maintain programming documentations following programming standards and processes. Create CDISC standard SDTM mapping specifications and ADaM specifications.
• Develop and oversee the development of SAS programs for the creation of SDTM and ADaM datasets following CDISC standards and reports (Tables, Listings and Figures).
• Contribute to the development of standard macros, participate in establishing and maintaining statistical programming standards.
• Participate in the CRF annotation, review of SAP, TLFs specifications development and TLFs review.
• Handle all P21 related items and eCRT pac.