PHARMAFull-time
Senior Stats Programmer (VAX)
By Admin · Biostatistics & Statistical Programming
HYDERABAD (IN)ONSITEPOSTED: 9/2/2026
PHARMAFull-time
HIRING ORGANIZATIONSANOFIPharmaceuticals / Biotechnology
ROLE DEFINITION & RESPONSIBILITIES
Job Overview
Full-time Senior Statistical Programmer position within Sanofi's Hyderabad Hub.
Supports the Vaccines R&D value chain as part of the Vaccines Global Biostatistical Sciences team.
Delivers biostatistics and statistical programming activities across Pre-Clinical, Clinical, Translational and CMC functions.
Supports statistical programming deliverables for clinical studies, integrated projects and regulatory submissions.
Requires strong expertise in SAS, CDISC standards, SDTM, ADaM, Tables Listings and Figures and clinical trial data analysis.
The role includes specialized exposure to vaccine clinical development, vaccine-specific study designs, endpoints and statistical methods.
Requires approximately 5-7 years of experience in statistical programming within clinical research.
Statistical Programming Deliverables
Perform programming activities for all required statistical deliverables.
Program SDTM datasets.
Program ADaM datasets.
Produce Tables, Listings and Figures.
Support statistical analyses conducted within individual clinical studies.
Support interim analyses.
Support final analyses.
Support analyses prepared for internal or external Data Monitoring Committees.
Support statistical surveillance activities.
Deliver statistical programming outputs for integrated and project-level analyses.
Support Integrated Summary of Safety activities.
Support Integrated Summary of Efficacy activities.
Support integrated statistical analyses.
Support Development Safety Update Reports.
Support Periodic Benefit-Risk Evaluation Reports.
Ensure programming outputs meet study, project and regulatory objectives.
Study Documentation Review
Review study protocols with particular focus on statistical sections.
Provide programming and statistical feedback on protocol documentation.
Review Case Report Forms.
Review Statistical Analysis Plans.
Review mock Tables, Listings and Figures.
Identify programming, data structure and analysis considerations during study documentation review.
Provide feedback to support the quality and feasibility of statistical programming deliverables.
Programming Specifications
Write programming specifications for SDTM datasets.
Write programming specifications for ADaM datasets.
Write programming specifications for Tables, Listings and Figures.
Develop specifications that support study and project objectives.
Independently create programming specifications when required.
Plan and draft specifications for integrated and pooled clinical data.
Ensure programming specifications are clear, complete and aligned with applicable standards.
CDISC & Regulatory Data Standards
Deliver compliant CDISC data packages.
Ensure SDTM and ADaM datasets comply with applicable CDISC standards.
Prepare and support annotated Case Report Forms.
Support preparation of Reviewer's Guides.
Support preparation and delivery of define.xml.
Apply controlled terminology requirements.
Manage value-level metadata requirements.
Support analysis results metadata.
Use P21 or related validation processes as required.
Ensure regulatory data packages fulfil Health Authority expectations.
Maintain appropriate documentation supporting regulatory data submissions.
Tables, Listings & Figures
Program and deliver Tables, Listings and Figures for clinical studies and projects.
Ensure TLF formats meet targeted publication requirements.
Support TLF outputs for Clinical Study Reports.
Support publication-related statistical outputs.
Support clinical trial transparency requirements.
Support disclosure and transparency outputs for systems and requirements such as EudraCT and ClinicalTrials.gov.
Support preparation of statistical outputs used for lay summaries.
Ensure presentation quality and consistency of programmed outputs.
Quality Control & Documentation
Perform quality control of statistical programming deliverables.
Prepare and maintain Validation Plans.
Complete Quality Control documentation.
Ensure programming outputs are accurate, reproducible and compliant.
Maintain documentation supporting validation and QC activities.
Identify and resolve programming or data quality issues.
Follow established quality processes for statistical programming deliverables.
Exploratory & Post-Hoc Analyses
Program exploratory analyses.
Support post-hoc analyses.
Perform programming activities where minimum specifications are available.
Apply statistical programming expertise and critical thinking to develop appropriate programming approaches.
Support additional analyses required to answer scientific and project questions.
Integrated Data & Pooling
Create core integrated clinical databases.
Pool SDTM datasets across multiple studies within an asset.
Pool ADaM datasets across multiple studies where required.
Work according to existing pooling specifications.
Plan and draft specifications for pooling clinical data from multiple studies.
Ensure integrated datasets support cross-study analyses and project-level reporting.
Maintain consistency and quality when combining data from multiple clinical studies.
Technical Programming Expertise
Demonstrate excellent SAS technical skills.
Use SAS Base for statistical programming activities.
Use SAS STAT for statistical analysis.
Use SAS Macro programming.
Use SAS Graph for graphical statistical outputs.
Use SAS SQL for data manipulation and querying.
Demonstrate familiarity with R.
Apply statistical programming methods to clinical research data.
Select appropriate programming approaches based on specifications and study requirements.
Independently solve complex programming and data issues.
Vaccines R&D Expertise
Support Vaccines Research and Development activities.
Apply knowledge of vaccine clinical development.
Understand vaccine-specific clinical trial designs.
Apply knowledge of vaccine endpoints.
Understand relevant vaccine statistical methods.
Support statistical programming activities across different stages of the Vaccines R&D value chain.
Work across Pre-Clinical, Clinical, Translational and CMC-related programming activities.
Clinical Research & Statistical Knowledge
Demonstrate a good understanding of processes associated with clinical trials.
Apply descriptive statistical concepts.
Understand clinical study data structures and analysis requirements.
Apply critical thinking beyond simply following predefined instructions or specifications.
Understand the relationship between protocols, CRFs, analysis plans, datasets and statistical outputs.
Support statistical programming activities across multiple concurrent assignments.
Project & Work Management
Organize multiple programming assignments effectively.
Establish priorities across competing deliverables.
Manage multiple work assignments within required timelines.
Demonstrate the ability to work independently.
Apply critical thinking and problem-solving when specifications are incomplete or complex.
Collaborate effectively with statisticians, programmers and cross-functional study teams.
Support efficient delivery of statistical programming outputs across the Vaccines portfolio.
Communication & Teamwork
Demonstrate strong interpersonal skills.
Work effectively within multidisciplinary and global teams.
Communicate technical programming and statistical information clearly.
Demonstrate highly effective English communication skills.
Communicate effectively both orally and in writing.
Collaborate with internal stakeholders supporting clinical development and statistical programming activities.
Education Requirements
Bachelor's degree in Statistics, Mathematics, Computer Science, related Health Sciences or another relevant discipline.
Master's degree in Statistics, Mathematics, Computer Science, related Health Sciences or another relevant discipline is also suitable.
Equivalent relevant professional experience may be considered.
Experience Requirements
Approximately 5-7 years of experience in statistical programming within clinical research.
Requires more than three years of SAS experience with strong technical expertise.
Vaccines experience is required or strongly expected, including exposure to vaccine study designs, endpoints or statistical methods.
Practical experience programming CDISC SDTM and ADaM datasets is required.
Experience developing programming specifications is required.
Experience pooling data from multiple studies is required.
Ability to independently create programming specifications is required.
Company & Career Environment
The Hyderabad Hub supports Sanofi's innovation and operational performance across the organization.
The role contributes to Sanofi's Vaccines R&D organization and global biostatistical sciences activities.
Sanofi develops and supplies vaccines globally and emphasizes scientific innovation in infectious disease prevention.
The organization promotes opportunities to contribute to scientific progress, healthcare innovation and global vaccine development.
Sanofi emphasizes equal opportunity and a diverse workforce across different backgrounds and experiences.
REQUIRED VERIFIED SKILLS
SAS
SAS Base
SAS STAT
SAS Macro
SAS Graph
SAS SQL
R
Statistical Programming
Clinical Research
Biostatistics
CDISC
SDTM
ADaM
Tables Listings and Figures
TLF Programming
Programming Specifications
Statistical Analysis
Interim Analysis
Final Analysis
Data Monitoring Committee Analysis
Statistical Surveillance
Integrated Summary of Safety
Integrated Summary of Efficacy
DSUR
PBRER
Protocol Review
CRF Review
Statistical Analysis Plan Review
Mock TLF Review
CDISC Data Package
Annotated CRF
Reviewer's Guide
Define.xml
Controlled Terminology
Value-Level Metadata
Analysis Results Metadata
P21 Validation
Quality Control
Validation Plan
QC Documentation
Exploratory Analysis
Post-Hoc Analysis
Clinical Data Pooling
Integrated Clinical Database
Descriptive Statistics
Clinical Trial Processes
Vaccines Clinical Research
Vaccine Study Designs
Vaccine Endpoints
Vaccine Statistical Methods
English Communication
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
No salary range or compensation figures are disclosed in the official job posting. Compensation for a Senior Statistical Programmer with approximately 5-7 years of clinical research programming experience may depend on SAS expertise, CDISC programming experience, vaccine therapeutic-area knowledge, data pooling expertise, educational qualifications and Sanofi's internal compensation structure. Candidates should discuss fixed compensation, annual performance incentives, insurance, retirement benefits, leave, learning and development opportunities and other total rewards components during the recruitment process. Specialized expertise in SDTM, ADaM, regulatory submission packages and vaccine clinical development may strengthen overall market positioning.
ORGANIZATION CONTEXT & CULTURE
Sanofi is a global biopharmaceutical company dedicated to human health. It researches, develops, manufactures, and markets innovative therapeutic solutions with a focus on specialty care, vaccines, general medicines, and consumer healthcare products. The company aims to prevent and treat a wide range of diseases worldwide.
TEAM SIZE: Approximately 90,000 employees
INDUSTRY: Pharmaceuticals / Biotechnology
EXPECTED CAREER ROADMAP
This Senior Statistical Programmer role provides a strong pathway toward advanced programming, biostatistics and clinical data leadership positions. Experience in the Vaccines R&D environment can support progression into Principal Statistical Programmer, Lead Statistical Programmer, Programming Team Lead, Biostatistics Programming Manager or global statistical programming leadership roles. Expertise in CDISC standards, regulatory data packages, integrated data pooling and advanced SAS programming can also create opportunities in regulatory programming, standards leadership, clinical data integration and programming strategy. The role's exposure across Pre-Clinical, Clinical, Translational and CMC activities provides broad scientific and technical development opportunities. Continued growth in R, advanced analytics, metadata standards and vaccine clinical development can further support leadership or specialized technical expert career pathways.
APPLICATION ADVISORY
Highlight your total years of statistical programming experience and clearly demonstrate 5-7 years of clinical research exposure. Place SAS expertise prominently on your resume and specifically mention Base, STAT, Macro, Graph and SQL capabilities. Provide detailed examples of SDTM and ADaM programming, including specification development, controlled terminology, value-level metadata, analysis results metadata, define.xml and Reviewer's Guides. Highlight experience creating Tables, Listings and Figures for interim and final analyses, Clinical Study Reports or regulatory submissions. If you have vaccine study experience, clearly describe vaccine designs, endpoints and statistical methods you supported. Include examples of pooling SDTM or ADaM data across multiple studies and independently developing pooling specifications. Prepare for interviews by reviewing CDISC implementation, SDTM and ADaM structures, P21 validation, programming quality control, metadata, integrated summaries and descriptive statistics. Be prepared to explain how you prioritize multiple programming deliverables and solve complex issues when specifications are incomplete.
RECOMMENDED TRAINING
1/5
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