Principal Stats Programmer (VAX)

Biopharma Careers; Hyderabad; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Sanofi in Hyderabad invites a Principal Statistical Programmer to join the Vaccines Global Biostatistical Sciences team. You will lead statistical programming deliverables across Pre-Clinical to Translational stages within the Vaccines R&D value chain.

You will write CDISC SDTM/ADaM specifications, supervise junior staff, ensure quality and timely deliverables, and collaborate with cross-functional teams to support regulatory submissions and publications.

Qualifications

• 8+ years in statistical programming for clinical research, vaccines a plus.
• Experience programming CDISC SDTM/ADaM datasets with vaccine specifics.
• Excellent knowledge of SAS BASE, STAT, MACRO, GRAPH, SQL, and R.
• Ability to lead complex projects and mentor junior staff.
• Experience with e-submission preparation is strongly preferred.

Responsibilities

• Plan and execute high-quality statistical programming deliverables for vaccine projects.
• Review study documents and create mock TLFs.
• Write and provide programming specifications for SDTM/ADaM/TLFs.
• Deliver CDISC data packages with all relevant documentation.
• Create core integrated clinical databases pooling SDTM/ADaM across studies.
• Ensure TLF formats meet publication and regulatory requirements.
• Lead junior staff and ensure timely, compliant deliveries.
• Perform quality control and document validation plans.
• Propose exploratory and post-hoc analyses when appropriate.
• Ensure compliance with SOPs and guidelines.

Skills

Leadership

Teamwork

Project management

Critical thinking

Scientific communication

Education

Bachelor's or Master's in Statistics/Mathematics/CS

Tools

SAS

R

SQL

Macros in SAS

GRAPH

Job description

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 Principal 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:

Plan and execute high quality and timely statistical programming deliverables in the context of a vaccine project

At study level for various analyses within a study:

Review and provide feedback on study documents (e.g.: protocol statistical section, Case Report Form, Statistical Analysis Plan (SAP)); create 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

At project level for various analyses within an asset:

Review and provide feedback on integrated analysis plan and create mock TLFs

Create core integrated clinical database, pooling SDTM/ADaM across several studies for different reporting purposes like ISS/ISE/ISI, DSUR, PBRER or safety surveillance

Ensure TLF’s format fulfil the requirements of targeted publishing (i.e.: clinical study report, publication, Transparency like Eudract, CTT.gov, lay summaries,...)

Take leadership, guiding more junior staff and ensuring quality and timely deliveries

Perform quality control for statistical programming deliverables and complete the associated documentation: Validation plan and quality control (QC) documentation.

Propose and Program exploratory and/or post’hoc analyses based on problem statement

Ensure compliance to SOP's, standards, and guidelines.

About you

You are a passionate leader with following experience and competences who like the challenge and growing into a new environment:

Experience:

8+ 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 in providing solutions for complex programming issues (including creation of complex macros), presenting alternatives and identifying the best solution

Experience pooling data from multiple studies according to existing specifications

Experience planning and drafting specifications for pooling data from multiple studies

Consistent successful experience as a lead on several concurrent studies/projects

e-submission preparation experience strongly preferred

Skills:

Good understanding of processes associated with clinical trials

Ability to independently create specifications

Knowledge of descriptive statistics

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

Ability to lead complex and large tasks, demonstration of strong project management skills

Education:

Bachelors or Masters degree in Statistics, Mathematics, Computer Science or related health sciences or equivalent experience

Languages:

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, 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 !