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Principal Biostatistician- Non-Clinical

3+ years
Not Disclosed
10 Dec. 3, 2024
Job Description
Job Type: Full Time Education: MS/PhD 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

Job Title: Principal Non-Clinical Biostatistician
Location: Hyderabad

About the Job:
As a Principal Non-Clinical Biostatistician, you will lead and support statistical activities for various non-clinical efficacy, safety studies, and Chemistry, Manufacturing, and Controls (CMC) activities. With minimal supervision, you’ll ensure high-quality statistical deliverables, contributing to Sanofi's innovation and scientific excellence. By joining our team, you’ll help transform how we innovate while positively impacting lives globally.

Key Responsibilities:

  • Statistical Expertise: Provide statistical support for non-clinical studies, enhancing reliability and scientific quality from target identification to process development.
  • Deliverables Management: Accountable for statistical deliverables for assigned studies or activities in non-clinical development.
  • Data Analysis: Perform statistical analyses using R, SAS, JMP, SIMCA, and internal tools to produce statistical reports or memos.
  • Study Design and Review: Design studies, determine sample sizes, and review study plans and reports according to best practices.
  • Tool Development: Contribute to the creation and maintenance of statistical end-user tools, particularly RShiny applications.
  • Methodology Innovation: Participate in internal working groups, developing cutting-edge statistical methodologies.
  • Animal Welfare: Optimize design and sample size for in vivo experiments in alignment with the Animal Welfare Committee (AWC).
  • Compliance: Adhere to internal policies, standards, and external regulatory guidelines.
  • Collaboration: Work cross-functionally, presenting results to project teams, stakeholders, and senior leadership.
  • Representation: Represent the statistics function in scientific and technology working groups or initiatives.

About You:

Experience:

  • Significant experience in the pharmaceutical or related industry with expertise in non-clinical statistics for biopharmaceutical development.
  • Proven skills in industrial statistics, including descriptive and inferential statistics, process control, design of experiments, and multivariate data analysis.
  • Familiarity with CMC regulatory guidelines (EMA, FDA, ICH Quality, Pharmacopeias) and Quality by Design (QbD) principles.

Soft and Technical Skills:

  • Strong interpersonal and communication skills.
  • Advanced proficiency in SAS, R, JMP, SIMCA, MODDE, and other statistical tools.
  • Knowledge of pharmaceutical R&D processes and regulatory requirements.
  • Ability to work independently and collaboratively in cross-functional teams.

Education:

  • Master’s or Ph.D. in Statistics or a related field.

Languages:

  • Fluency in English, both written and spoken.

Why Choose Us?

  • Be part of a future-focused, supportive team driving scientific innovation.
  • Access endless career growth opportunities through promotions, lateral moves, or international assignments.
  • Enjoy a competitive rewards package recognizing your contributions.
  • Benefit from extensive health and wellbeing programs, including high-quality healthcare and at least 14 weeks of gender-neutral parental leave.

Pursue Progress. Discover Extraordinary.
Progress is made by people—diverse individuals in different locations, united by a shared passion for innovation. Join us to embrace change, explore new ideas, and make miracles happen. Together, let’s pursue progress and discover extraordinary.

Diversity and Inclusion at Sanofi:
We are committed to fostering a diverse and inclusive environment, providing equal opportunities to all, regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Discover more about our Diversity, Equity, and Inclusion initiatives and what it’s like to work at Sanofi at sanofi.com.

Apply Now
Be a part of the transformation and make a meaningful impact today.