Senior Manager, Statistical Programming
Job Details
Company: Sun Pharmaceutical Industries Ltd.
Business Unit: Global Clinical Development
Job Grade: G9
Location: Gurgaon – R&D
Work Model: Remote/Hybrid
Date Posted: September 5, 2026
Experience: 12+ years
Employment Type: Full-time
Role Overview
The Senior Manager, Statistical Programming will provide comprehensive statistical programming and people-management expertise to lead and support programming activities across clinical development projects.
The role requires independent execution of programming strategies and project standards supporting ongoing clinical studies, study reports, regulatory submissions, and ad hoc/post hoc analyses.
The Senior Manager will work closely with internal partnering functions, stakeholders, and external functional service providers to ensure timely, high-quality programming deliverables.
The position also contributes to departmental goals, SOPs, programming macros, SME initiatives, and technical guidance, particularly around CDISC standards.
Key Responsibilities
Statistical Programming Leadership
Lead statistical programming activities for a therapeutic area, compound, or indication across multiple studies and projects.
Oversee programming activities across different stages of clinical studies.
Ensure timely and high-quality programming deliverables.
Independently implement and execute programming strategies and project standards.
Support study reports, regulatory submissions, ad hoc analyses, and post hoc analyses.
Provide technical expertise and guidance for complex programming activities.
Ensure programming activities align with clinical development and project requirements.
SAS Programming
Develop and oversee SAS programs for clinical trial data processing.
Create and review SDTM datasets according to CDISC standards.
Create and review ADaM datasets according to CDISC standards.
Develop and review Tables, Listings, and Figures (TLFs).
Ensure programming outputs meet quality and specification requirements.
Apply advanced SAS programming skills in a clinical data environment.
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 regulatory guidance and Therapeutic Area User Guides (TAUGs).
Provide technical guidance on CDISC implementation.
Support development and maintenance of CDISC programming standards.
Ensure clinical datasets and associated deliverables comply with applicable standards.
Programming Standards and Documentation
Develop and maintain programming documentation.
Follow established programming standards and processes.
Participate in establishing and maintaining statistical programming standards.
Contribute to development of standard SAS macros.
Support department-level SOP development and implementation.
Participate in training guideline development.
Contribute to SME topics and technical initiatives.
Provide technical guidance on programming standards and best practices.
Clinical Trial Documentation
Participate in Clinical Report Form (CRF) annotation activities.
Review Statistical Analysis Plans (SAPs).
Participate in TLF specification development.
Review TLF specifications and outputs.
Ensure programming deliverables are consistent with statistical and clinical requirements.
Regulatory Submission Support
Manage P21-related activities.
Handle eCRT package deliverables for regulatory submissions.
Support preparation and review 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:
FDA
EMA
PMDA
Other applicable regulatory agencies
Support global regulatory authority submissions.
Follow applicable regulatory guidance and submission standards, including:
SDTCG
DSC
eCTD
Collaborate 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 the scope of work for assigned projects.
Plan programming deliverables and timelines with study teams, programming leads, and management.
Coordinate programming activities across multiple studies and projects.
Monitor delivery timelines and quality.
Identify risks to programming deliverables.
Escalate issues and implement appropriate solutions.
Ensure project deliverables are completed according to agreed standards and timelines.
Coordinate with external functional service providers as required.
People Management and Mentoring
Manage and mentor new hires and junior statistical programmers.
Provide technical guidance and coaching to team members.
Support employee development and knowledge sharing.
Promote a positive and collaborative working environment.
Monitor team deliverables and support effective workload management.
Encourage adherence to programming standards and best practices.
Build technical capability within the statistical programming team.
Cross-Functional Collaboration
Work closely with internal partnering functions.
Collaborate with clinical study teams and statistical functions.
Partner with regulatory and other functional stakeholders.
Coordinate with external functional service providers.
Participate in global interdisciplinary teams.
Maintain effective communication across functions and geographies.
Support resolution of cross-functional issues affecting programming deliverables.
Process Improvement and Innovation
Contribute to department goals and strategic initiatives.
Participate in SOP development and improvement.
Contribute to programming standards and training guidelines.
Develop and improve reusable programming macros.
Identify opportunities to improve programming efficiency and quality.
Participate in SME initiatives.
Promote innovative approaches to clinical programming and data challenges.
Technical Skills
Advanced SAS programming skills.
Strong experience with SAS in a clinical data environment.
Strong analytical and problem-solving skills.
Experience with SDTM and ADaM programming.
Experience developing and reviewing TLFs.
Strong understanding of CDISC standards.
Knowledge of TAUGs.
Experience with regulatory submission programming.
Experience with P21 and eCRT deliverables.
Working knowledge of R and/or Python is an advantage.
SAS certification is an advantage.
Clinical Development Knowledge
Excellent understanding of pharmaceutical clinical development.
Strong knowledge of statistical concepts and techniques.
Strong understanding of clinical trial principles.
Understanding of clinical data structures and standards.
Knowledge of clinical study reporting requirements.
Strong understanding of regulatory submissions.
Knowledge of NDA and ANDA submissions.
Understanding of regulatory agency expectations.
Regulatory and Submission Knowledge
Relevant knowledge includes:
FDA
EMA
PMDA
NDA
ANDA
eCTD
SDTCG
DSC
P21
eCRT
Define.xml
aCRF
cSDRG
ADRG
ARM
Required Qualification
Minimum Bachelor’s degree in:
Statistics
Computer Science
Mathematics
Engineering
Life Sciences
Related discipline
Required Experience
12+ years of statistical programming experience.
Experience processing clinical trial data.
Experience in biotechnology, pharmaceutical, CRO, or healthcare industries.
Strong hands-on SAS programming experience.
Experience with CDISC standards.
Experience with regulatory submission programming.
Experience with clinical trial reporting.
Experience managing people and programming processes.
Experience working with global interdisciplinary teams.
Professional and Behavioral Competencies
Strong leadership skills.
Excellent organizational skills.
Strong interpersonal and communication skills.
Ability to work independently.
Ability to lead global interdisciplinary teams.
Positive and collaborative attitude.
Strong team-player mindset.
Growth mindset.
Strong ownership and accountability.
Initiative and motivation.
Innovative problem-solving capabilities.
Ability to manage multiple priorities and deadlines.
Ability to mentor and develop junior team members.
Key Functional Areas
Statistical Programming
SAS Programming
Clinical Data Programming
SDTM
ADaM
CDISC
TLF Programming
Clinical Trial Reporting
Regulatory Submission Programming
Regulatory Data Standards
Programming Standards
SAS Macros
Clinical Development
Data Analysis
Project Management
Technical Leadership
People Management
Team Development
Process Improvement
Key Deliverables
The Senior Manager may be responsible for delivering or overseeing:
SDTM datasets
ADaM datasets
Tables
Listings
Figures
SDTM mapping specifications
ADaM specifications
SAS programs
Standard SAS macros
CRF annotations
SAP reviews
TLF specifications
P21 deliverables
eCRT packages
aCRF
Define.xml
cSDRG
ADRG
ARM
Regulatory submission datasets
Study reports
Ad hoc analyses
Post hoc analyses
Leadership Scope
The Senior Manager position combines advanced technical expertise with people management, project leadership, regulatory submission support, and strategic programming oversight.
Compared with the Manager 1 position, this role places greater emphasis on:
Leadership of multiple studies/projects
People management
Mentoring and coaching
CDISC technical leadership
Programming standards
Cross-functional influence
Global collaboration
Complex regulatory submissions
Process improvement
Department-level contributions
Ideal Candidate Profile
The ideal candidate is a senior clinical statistical programming professional with 12+ years of pharmaceutical, biotechnology, CRO, or healthcare experience.
The candidate should possess strong hands-on SAS programming expertise combined with advanced knowledge of CDISC, SDTM, ADaM, TLFs, clinical trial data, and regulatory submissions.
The position is particularly suited to an experienced professional who can balance hands-on technical programming with people leadership, project oversight, regulatory submission responsibilities, mentoring, and development of programming standards.
Company Culture
Sun Pharma promotes continuous development, ownership, collaboration, innovation, teamwork, accountability, and professional growth. The company encourages employees to take charge of their careers while contributing to global clinical development objectives.
Role Expectations
The Senior Manager is expected to provide both technical and people leadership within statistical programming.
The successful candidate should be capable of independently managing complex clinical programming activities, guiding teams, supporting global regulatory submissions, mentoring programmers, establishing programming standards, and contributing to departmental strategy and process improvement.
The role requires strong technical judgment, leadership capability, regulatory knowledge, and the ability to deliver high-quality programming outputs within demanding clinical development timelines.
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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