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Principal Biostatistician-Clinical Statistics

2+ years
Not Disclosed
10 Dec. 10, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Principal Biostatistician
Location: Hyderabad, India

About the Job
At Sanofi, we are driven by the mission to chase the miracles of science to improve people's lives. As a Principal Biostatistician within our Clinical Statistics Team, you will lead or support early and late-phase clinical studies with minimal supervision. You will play a crucial role in ensuring the statistical integrity of clinical data and contribute to the design and execution of studies that shape the future of medicine. This position offers the opportunity to work on impactful projects while growing your career in a global healthcare environment.

Major Responsibilities

  • Support the design and setup of clinical studies, including protocol development and statistical analysis plans (SAP).
  • Conduct statistical analyses as per the SAP, ensuring the statistical integrity of results and compliance with internal standards, regulatory guidelines, and SOPs.
  • Be accountable for all statistical deliverables for assigned studies or domains, including statistical sections of protocols, sample size calculations, randomization specifications, SAP, data surveillance, and statistical analysis results for clinical study reports (CSR).
  • Propose, prepare, and perform exploratory data analyses and ad-hoc analyses relevant to the study’s objectives.
  • Contribute to transparency and disclosure deliverables.
  • Collaborate with the programming team to define, document, and review derived variables, ensuring quality control throughout the process.
  • Review and examine statistical data distributions and properties for accuracy and relevance.
  • Ensure effective collaboration within aligned study teams, safety monitoring teams, and senior leadership, fostering teamwork, quality, operational efficiency, and innovation.
  • Represent statistics in scientific or technology working groups and cross-functional initiatives.

About You

  • Experience: Background in the pharmaceutical or related industry, with clinical trial experience.
  • Skills: Strong understanding of statistical concepts and techniques. Demonstrated interpersonal and communication skills.
  • Technical Proficiency: Advanced skills in statistical analysis using SAS, R, and other languages.
  • Education: MS or PhD in Statistics or a related field.
  • Languages: Proficiency in English, both written and oral, with effective communication skills.

Why Choose Us?

  • Career Growth: Endless opportunities to grow your skills and advance your career, whether through promotions or lateral moves, locally or globally.
  • Innovative Environment: Join a forward-looking team at the cutting edge of biopharmaceutical development.
  • Comprehensive Rewards: Receive a competitive rewards package that values your contributions and amplifies your impact.
  • Health & Wellbeing: Access to a range of health and wellness benefits, including high-quality healthcare, prevention programs, and at least 14 weeks of gender-neutral parental leave.
  • Global Impact: Gain international experience working on clinical trials and engaging with health authorities worldwide.