Principal Stats Programmer (VAX)

Sanofi Group; Hyderabad; On-site; INR 350,000 - 650,000; Full time

Job summary

Sanofi Group in Hyderabad seeks a Principal Statistical Programmer to lead vaccine-related statistical programming activities across Pre-Clinical to CMC stages. You will guide a performing team delivering CDISC SDTM/ADaM datasets, provide programming specifications, and ensure quality compliant data packages for Health Authorities.

The role requires 8+ years in statistical programming, strong SAS expertise, CDISC experience, and leadership capabilities to manage multiple studies and deliver on

Qualifications

• 8+ years experience in statistical programming in clinical research, vaccines experience preferred.
• SAS (BASE, MACRO, GRAPH) and CDISC SDTM/ADaM development.
• Experience leading multiple studies and providing complex programming solutions.
• e-submission preparation experience strongly preferred.

Responsibilities

• Plan and execute high-quality statistical programming deliverables for vaccine projects.
• Write programming specs for SDTM/ADaM and TLFs to support study objectives.
• Develop core integrated clinical databases pooling SDTM/ADaM across studies for ISS/ISE/ISI, DSUR, PBRER or safety surveillance.
• Lead and mentor junior staff to ensure timely and quality deliveries.
• Perform QC and maintain validation and QC documentation.
• Propose exploratory analyses based on problem statements and ensure SOP compliance.

Skills

SAS programming

CDISC SDTM/ADaM

Clinical research

Leadership

Data pooling

Post-hoc analysis

Project management

Education

Statistics/Mathematics/CS degree

Tools

SAS

R

SQL

define.xml

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 Health 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 specificationsExperience 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