Principal Biostatistician – Clinical Statistics | Hyderabad, India | Full-Time
Location: Hyderabad, Telangana, India
Experience Required: 8+ years in clinical statistics / biostatistics within pharmaceuticals or clinical research
Industry: Pharmaceuticals / Clinical Research / Biostatistics
Employment Type: Full-Time
About Sanofi
Sanofi is a global biopharmaceutical leader dedicated to improving health outcomes worldwide. With a focus on vaccines, oncology, rare diseases, and neurology, our teams combine deep scientific expertise with AI-driven innovation to advance clinical research and deliver transformative therapies.
Our Hyderabad Hub is a core part of Sanofi’s global innovation ecosystem, driving scientific excellence and operational efficiency in clinical statistics. This role offers an opportunity to contribute to cutting-edge clinical research and collaborate with multidisciplinary teams to impact millions of patients globally.
Role Overview
The Principal Biostatistician – Clinical Statistics will provide leadership and expertise across early and late-phase clinical trials. Reporting to the statistical team leader, you will oversee the statistical design, execution, analysis, and interpretation of clinical studies, ensuring compliance with regulatory guidelines and internal SOPs.
This position is ideal for experienced biostatisticians who want to lead critical projects, mentor teams, and influence strategic statistical decisions within a global pharmaceutical setting.
Key Responsibilities
Clinical Study Design & Execution:
Support clinical protocol development, study setup, and trial conduct.
Provide statistical input for study design, including sample size calculations, randomization schemes, and methodology specifications.
Ensure statistical integrity in study reports, publications, and regulatory submissions.
Data Analysis & Reporting:
Conduct statistical analyses in accordance with the Statistical Analysis Plan (SAP).
Collaborate with programming teams to define variables, implement quality control, and review analysis outputs.
Perform exploratory and ad-hoc analyses to support study or project objectives.
Review statistical distributions, results, and interpretations for accuracy and regulatory compliance.
Leadership & Collaboration:
Lead or support one or more studies, mentoring junior statisticians and guiding best practices.
Collaborate effectively with cross-functional teams, including clinical operations, safety monitoring, and medical writing.
Represent the statistical function in scientific or technology working groups and cross-functional initiatives.
Promote teamwork, operational efficiency, and innovation in biostatistical processes.
Regulatory & Compliance:
Ensure all statistical deliverables adhere to internal SOPs, ICH/GCP guidelines, and Health Authority requirements.
Contribute to Transparency and Disclosure activities for clinical trials.
Required Experience & Skills
Experience: 8+ years in clinical statistics/biostatistics within pharmaceutical or clinical research settings. Experience in global clinical trials preferred.
Technical Skills: Proficiency in SAS, R, and other statistical programming tools; strong understanding of advanced statistical concepts and methods.
Clinical Knowledge: In-depth knowledge of clinical development processes, clinical trial design, and regulatory requirements.
Leadership & Collaboration: Proven ability to lead study-level statistical activities, mentor junior staff, and collaborate with cross-functional global teams.
Soft Skills: Strong analytical, critical thinking, and communication skills with the ability to clearly present statistical insights to non-statistical stakeholders.
Educational Requirements
Master’s or PhD in Statistics, Biostatistics, Mathematics, or related health sciences.
Fluency in English with highly effective written and oral communication skills.
Why Join Sanofi
Contribute to global clinical research projects that impact millions of lives.
Gain exposure to international clinical trial practices and interact with global Health Authorities.
Enjoy a comprehensive benefits package including healthcare, wellness programs, parental leave, and career development opportunities.
Collaborate within a supportive, innovative, and inclusive environment.
Advance your career as an influential biostatistician in a global pharmaceutical organization.
Sanofi is an equal opportunity employer, committed to diversity, equity, and inclusion. All qualified applicants will receive consideration regardless of race, color, ancestry, religion, sex, sexual orientation, gender identity, age, disability, or other legally protected characteristics.
Apply now to lead statistical excellence in clinical research and shape the future of innovative therapies at Sanofi Hyderabad.
Gujarat :
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