Manager 1, Statistical Programming
Job Details
Company: Sun Pharmaceutical Industries Ltd.
Business Unit: Global Clinical Development
Job Grade: G10
Location: Gurgaon – R&D
Work Model: Remote/Hybrid
Date Posted: September 2, 2026
Experience: 8–10+ years
Employment Type: Full-time
Role Overview
The Manager 1, Statistical Programming will provide comprehensive statistical programming expertise to lead and support programming activities across clinical development projects.
The role involves independently implementing programming strategies and project standards to support ongoing clinical studies, study reports, regulatory submissions, and ad hoc/post hoc analyses.
The position requires close collaboration with internal stakeholders, partnering functions, and external functional service providers to ensure programming deliverables are completed on time and meet high-quality standards.
The Manager 1 will also contribute to departmental objectives, Standard Operating Procedures (SOPs), programming standards, macros, subject matter expert (SME) activities, and technical guidance for complex programming tasks.
Key Responsibilities
Statistical Programming Leadership
Lead statistical programming activities for a therapeutic area, compound, or indication across multiple studies and projects.
Manage programming activities throughout different stages of clinical studies.
Ensure timely and high-quality programming deliverables.
Plan programming activities in collaboration with study teams, programming leads, and management.
Independently execute programming activities according to project strategies and standards.
Support clinical study reporting and regulatory submission requirements.
Perform ad hoc and post hoc analyses as required.
SAS Programming
Develop and oversee SAS programs for clinical trial data processing.
Create SDTM datasets according to CDISC standards.
Create ADaM datasets according to CDISC standards.
Develop Tables, Listings, and Figures (TLFs).
Review programming outputs for accuracy, quality, and compliance with specifications.
Apply SAS programming expertise to complex clinical data programming activities.
Support programming activities throughout the clinical development lifecycle.
CDISC Standards
Develop CDISC-compliant SDTM mapping specifications.
Develop ADaM specifications.
Implement CDISC standards across clinical programming activities.
Apply relevant CDISC implementation guides and Therapeutic Area User Guides (TAUGs).
Ensure datasets and programming deliverables comply with applicable CDISC standards.
Support continuous improvement of CDISC implementation practices.
Programming Documentation and Standards
Develop and maintain programming documentation.
Follow established programming standards and processes.
Contribute to the development and maintenance of statistical programming standards.
Develop and maintain standard SAS macros.
Contribute to departmental SOPs and training guidelines.
Participate in SME topics and technical initiatives.
Provide technical guidance on complex programming tasks.
Clinical Trial Documentation
Participate in Clinical Report Form (CRF) annotation activities.
Review Statistical Analysis Plans (SAPs).
Participate in development and review of TLF specifications.
Review final TLF outputs.
Ensure programming activities are aligned with study specifications and statistical requirements.
Regulatory Submission Support
Manage P21-related activities.
Prepare and review eCRT packages for regulatory submissions.
Support preparation of:
Annotated CRF (aCRF)
Define.xml
Clinical Study Data Reviewer's Guide (cSDRG)
Analysis Data Reviewer's Guide (ADRG)
Analysis Results Metadata (ARM)
Support regulatory submissions to agencies including:
FDA
EMA
PMDA
Other applicable health authorities
Support global regulatory authority submissions.
Follow applicable regulatory submission standards and guidance, including:
SDTCG
DSC
eCTD
Work closely with partnering functions to address health authority requests.
Support responses to regulatory questions related to clinical datasets and statistical programming.
Project Planning and Delivery
Understand project scope, deliverables, priorities, and timelines.
Develop programming plans in collaboration with the study team.
Coordinate with programming leads and management.
Monitor progress against agreed timelines.
Identify potential delivery risks and escalate issues appropriately.
Ensure assigned deliverables are completed according to project standards.
Coordinate with external functional service providers when required.
Cross-Functional Collaboration
Work closely with internal partnering functions.
Collaborate with clinical study teams and statistical functions.
Work with regulatory and other functional stakeholders.
Coordinate with external functional service providers.
Participate in global interdisciplinary teams.
Maintain effective communication across different functions and geographic locations.
People Management, Mentoring and Coaching
Mentor new hires and junior statistical programmers.
Coach team members on programming standards and best practices.
Provide technical guidance on complex programming activities.
Support knowledge sharing within the statistical programming team.
Contribute to employee development and capability-building initiatives.
Process Improvement and Innovation
Contribute to department-level goals and initiatives.
Participate in SOP development and improvement.
Contribute to programming standards and training guidelines.
Develop and improve reusable SAS macros.
Identify opportunities to improve programming efficiency and quality.
Apply innovative approaches to solve programming and data-related problems.
Participate in SME initiatives and technical improvement projects.
Technical Skills
Strong SAS programming skills.
Experience with SAS programming in a clinical data environment.
Strong analytical and problem-solving skills.
Knowledge of clinical trial data processing.
Experience with SDTM and ADaM programming.
Experience with TLF development.
Knowledge of CDISC standards.
Experience with regulatory submission datasets and documentation.
Knowledge of P21 and eCRT packages.
Working knowledge of R and/or Python is an advantage.
SAS certification is an advantage.
Clinical Development Knowledge
Strong understanding of pharmaceutical clinical development.
Knowledge of clinical trial principles.
Understanding of statistical concepts and techniques.
Knowledge of clinical data structures and standards.
Understanding of regulatory submission requirements.
Knowledge of regulatory submissions such as NDA and ANDA.
Understanding of regulatory agency expectations.
Knowledge of CDISC implementation standards and TAUGs.
Regulatory Knowledge
The candidate should have working knowledge of clinical data regulatory submission requirements and standards, including:
FDA submissions
EMA submissions
PMDA submissions
NDA
ANDA
eCTD
SDTCG
DSC
P21
eCRT
Define.xml
aCRF
cSDRG
ADRG
ARM
Required Qualifications
Minimum Bachelor’s degree in:
Statistics
Computer Science
Mathematics
Engineering
Life Sciences
Related discipline
Required Experience
8–10+ years of statistical programming experience.
Experience processing clinical trial data.
Experience in one or more of the following industries:
Biotechnology
Pharmaceutical
Contract Research Organization (CRO)
Healthcare
Strong hands-on SAS programming experience.
Experience with clinical trial programming and regulatory submissions.
Experience working with global and interdisciplinary teams.
Experience with people and process management.
Professional and Behavioral Competencies
Strong organizational skills.
Excellent interpersonal skills.
Strong written and verbal communication.
Ability to work independently.
Ability to work effectively within global teams.
Positive and collaborative attitude.
Strong team-player mindset.
Growth mindset.
Strong ownership and accountability.
Initiative and motivation.
Innovative problem-solving approach.
Ability to manage multiple priorities.
Ability to work within strict project timelines.
Ideal Candidate Profile
The ideal candidate is an experienced clinical statistical programmer with 8–10+ years of pharmaceutical, biotechnology, CRO, or healthcare industry experience.
The candidate should have strong hands-on SAS programming expertise combined with knowledge of CDISC, SDTM, ADaM, TLFs, clinical trial data, and regulatory submissions.
The role is particularly suited to someone who can operate independently while also providing technical leadership, mentoring junior programmers, managing programming processes, and collaborating effectively with global cross-functional teams.
Key Functional Areas
Statistical Programming
Clinical Data Programming
SAS Programming
SDTM
ADaM
CDISC
TLF Programming
Regulatory Submission Programming
Clinical Trial Reporting
Regulatory Data Standards
Programming Standards
SAS Macros
Statistical Analysis Support
Clinical Development
Data Review
Project Management
Technical Leadership
People Development
Key Deliverables
The role may be responsible for delivering and/or overseeing:
SDTM datasets
ADaM datasets
Tables
Listings
Figures
SDTM mapping specifications
ADaM specifications
SAS programs
Standard SAS macros
CRF annotations
TLF specifications
P21 deliverables
eCRT packages
aCRF
Define.xml
cSDRG
ADRG
ARM
Regulatory submission datasets
Ad hoc analyses
Post hoc analyses
Clinical study reporting deliverables
Company Culture
Sun Pharma emphasizes continuous development, ownership, collaboration, innovation, teamwork, accountability, and professional growth. The organization encourages employees to take charge of their careers while contributing to shared business and scientific objectives.
Role Expectations
The Manager 1 is expected to combine strong technical statistical programming expertise with project ownership, cross-functional collaboration, and people development.
The successful candidate should be capable of independently managing complex programming activities, ensuring regulatory-quality deliverables, supporting global submissions, mentoring junior programmers, and contributing to department-wide standards and process improvements.
Disclaimer
This job description describes the general nature and level of work expected for the position. It is not intended to be a comprehensive list of all responsibilities, duties, or qualifications. Sun Pharma may modify responsibilities or assign comparable duties based on business requirements and the employee’s experience and background.
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