Principal Biostatistician (VAX)

Sanofi; Hyderabad; On-site; INR 600,000 - 900,000; Full time

Job summary

Sanofi Hyderabad Hub is seeking a Principal Biostatistician to lead statistics and programming across the Vaccines R&D value chain, including Pre-Clinical, Clinical, Translational, and CMC activities. You will collaborate with the Global Biostatistical Sciences team to deliver robust analyses and support regulatory submissions.

You will guide study design, analysis plans, and interpretation of results while mentoring programmers, coordinating with cross-functional teams, and communicating with

Qualifications

• 8+ years in clinical Biostatistics and Programming research, 3–5 years in Vaccines.
• End-to-end study Biostatistician experience including protocol and analysis.
• Experience leading programmers in e-submission activities (ISS/ISE/ISI).
• Strong exploratory analysis skills without predefined specs.
• Proven lead on multiple concurrent studies with SAS and R.
• Knowledge of CDISC SDTM/ADaM/SEND and define.xml.

Responsibilities

• Support clinical study design, setup, conduct and reporting.
• Deliver statistical study deliverables and create SAPs and analyses.
• Develop Integrated Analysis Plans for Safety/Immunology and Dossiers.
• Coordinate with programming for variable definitions and QC plans.
• Produce CDISC-compliant data packages for submission.
• Provide statistical insights and present methods and implications clearly.

Skills

Biostatistics

Programming (SAS)

Programming (R)

CDISC SDTM/ADaM

Study design

Leadership

Project management

Communication

Team collaboration

Vaccine trial experience

Education

PhD or MSc in Statistics

Tools

SAS

R

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 Biostatistician 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

• Support the clinical study design (including concept protocol development), the study setup, conduct and reporting.
• Accountable for all assigned statistical study deliverables: develop statistical sections in protocol (i.e. statistical methodology, sample size calculation, …); ensure protocol is statistically sound; contribute to randomization specifications and set-up; develop Statistical Analysis Plan; plan and execute statistical data surveillance; perform data analysis; contribute to interpretation of results with the Project Biostatistician; ensure clinical study report statistical integrity and the specific deliverables related to Transparency and Disclosure
• Develop Integrated Analysis Plan for Safety or Immunology Summaries. Conduct related analyses in collaboration with programming and deliver outputs for submission Core Technical Dossier
• Work with the programming team to provide definitions, documentation and review of derived variables, as well as the quality control plan. Perform and/or coordinate with study programmer the production of statistical analyses and CDISC compliant data package, ready for submission
• Propose, prepare and perform complex exploratory data analyses, ad-hoc analyses as relevant for the study or project objectives and/or in answering Health Authorities questions
• Provide statistical insight into interpretation of results in line with other sponsored studies and competition results. Use strong communication skills to present and explain the methodology chosen and consequences in results interpretation and decisions
• Ensure productive collaborations with other functions in the aligned study team and/or safety monitoring team and in communicating with senior leadership.; Promoting teamwork, quality, operational efficiency, and innovation.
• Represent statistics to participate in scientific or technology working groups or cross function initiatives

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 clinical Biostatistics and Programming research, including at least 3-5 years in Vaccines (trial designs, endpoints, statistical methods, …)
• Experience in acting end to end as Study Biostatistician (ie, non-standard sample size, statistical section of protocol, randomization set-up with vendor, Statistical Analysis Plan, analyses, study report, publication…)
• Experience in leading programmers through some e-submission statistical activities (e.g. ISS, ISE, and/or ISI)
• Experience in performing complex exploratory statistical analyses without written specifications
• Consistent successful experience as a lead on several concurrent studies/projects (programming experience in SAS and R)
• Demonstrate knowledge of CDISC (SDTM/ADaM/SEND) including specifications, P21, define.xml, Reviewers Guide

Skills

• Excellent understanding of processes associated with clinical trials, including knowledge of interfaces and interdependencies with other functions
• Demonstrate interpersonal/teamwork in technical and leadership skills
• Strong projects management skills
• Clear ability to organize multiple work assignments to a team and establish priorities
• Understand and able to contribute to resourcing strategy implementation, developing capacities and capabilities
• Eager to learn and explore new territories

Education

• PhD or Masters degree in Statistics (preferred), Mathematics or related health sciences or equivalent experience

Languages

• English: Highly effective communication, both oral and written.

Why choose us?

From providing protection against disease at every stage of life to protecting humanity against emerging epidemics, vaccines help create and maintain healthy communities that keep life moving forward. With a clear and strong ambition to deliver a robust Vaccines portfolio, we aim to create an environment that

• Brings the miracles of science to life alongside a supportive, future-focused team
• Provides opportunities for people to learn, gain experience and share knowledge
• Is obsessed by leveraging your expertise in bringing data to life at the heart of decision making
• Values team work and collaboration, taking care of each other, rowing all in the same direction to the finish line
• Nurtures diversity and inclusion, complementing each others
• Seeks constantly opportunities to re-invent ourselves
• This role is critical to our team’s success and offers exposure to a broad range of activities within Biostatistics and Programming and a broad range of stakeholders.