Senior Stats Programmer (VAX)

Biopharma Careers; Hyderabad; On-site; INR 1,500,000 - 3,000,000; Full time

Job summary

Sanofi Hyderabad Hub seeks a Senior Statistical Programmer to join a high‑performing team. You will deliver biostatistics and programming for vaccines across Pre‑Clinical to CMC, ensuring CDISC data packages meet regulatory expectations.

You will program SDTM/ADaM datasets, review SAPs, create specifications, and uphold QC standards while collaborating across study teams and external partners.

Qualifications

• 5-7 years in statistical programming for clinical research, vaccines preferred.
• Experience with SDTM/ADaM datasets and CDISC standards.
• Ability to write programming specifications and QC documentation.

Responsibilities

• Perform programming for SDTM/ADaM datasets and TLFs for studies and projects.
• Review study documents (SAP, CRF, protocol) and provide feedback.
• Create SDTM/ADaM specifications and deliver compliant CDISC data packages.
• Ensure QC and generate documentation for regulatory expectations.
• Contribute to pooling data across studies and initiating analyses.

Skills

SAS programming

CDISC SDTM/ADaM

Vaccines experience

Data pooling

Statistical methods

English communication

Education

Bachelor's or Master's in Statistics/Math/CS or related health sciences

Tools

BASE SAS

MACRO

GRAPH

SQL

R

Job description

Senior Statistical Programmer

Location: Hyderabad

About the job

Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives.

Ready? As a Senior Statistical Programmer within our Hyderabad Hub, you’ll be part of a performing team, delivering biostatistics and programming activities throughout the Vaccines R&D value chain (Pre-Clinical, Clinical, Translational, CMC) with our Vaccines Global Biostatistical Sciences team.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main responsibilities

• Perform programming activities for all statistical deliverables (i.e.: SDTM, ADaM, Tables Listings and Figures (TLF)) for various analyses within a study (e.g.: interim/final analyses, internal or external data monitoring committees, statistical surveillance) or within a project (i.e.: ISS, ISE, ISI, DSUR, PBRER,)
• Review and provide feedback on study documents, such as protocol (statistical section), Case Report Form (CRF), Statistical Analysis Plan (SAP) and mock TLFs
• Write and provide the programming specifications for the SDTM/ADaM/TLFs to fulfil the study or project objectives
• Deliver compliant CDISC data package with all relevant documentation (ie: aCRF, reviewers guide, define.xml) fulfilling Heath Authorities expectations
• Ensure TLF’s format fulfil the requirements of targeted publishing (i.e.: clinical study report, publication, Transparency like Eudract, CTT.gov, lay summaries,)
• Perform quality control for statistical programming deliverables and complete the associated documentation: Validation plan and quality control (QC) documentation.
• Program exploratory and/or post’hoc analyses with minimum specifications
• Create core integrated clinical database, pooling SDTM/ADaM datasets across several studies within an asset
• Ensure compliance to SOP's, standards, and guidelines.

About you

• 5-7 years' experience in statistical programming clinical research with some Vaccines experience (designs, endpoints, statistical methods, …)
• SAS ( >3 years): excellent technical skills in BASE, STAT, MACRO, GRAPH, SQL, R, and familiar in statistical programming
• Experience programming CDISC SDTM/ADaM datasets and notably vaccines specifics (including writing specifications, P21, proficiency with controlled terminology, value-level metadata, analysis results metadata, define.xml, Reviewers Guide)
• Experience pooling data from multiple studies according to existing specifications
• Experience planning and drafting specifications for pooling data from multiple studies
• Ability to independently create specifications
• Knowledge of descriptive statistics
• Good understanding of processes associated with clinical trials
• Demonstrate interpersonal skills necessary for effective teamwork
• Demonstrate ability to organize multiple work assignments and establish priorities
• Demonstrate critical thinking skills beyond simply following directions or specifications
• Bachelors or Masters degree in Statistics, Mathematics, Computer Science or related health sciences or equivalent experience
• English: Highly effective communication, both oral and written

Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !