Principal Biostatistician-Clinical Statistics

2+ years

Not Disclosed

Hyderabad

10 Nov. 15, 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

Job Title: Principal Biostatistician
Location: Hyderabad, India

About the Role:
As a Principal Biostatistician at Sanofi, you will be a key member of our Clinical Statistics Team, leading or supporting multiple early and late-phase studies with minimal supervision. You will be responsible for ensuring the statistical integrity of clinical studies, contributing to protocol development, statistical analysis, and providing key insights for clinical study reports (CSRs) and publications.

Key Responsibilities:

Lead the design of clinical studies, including protocol development and statistical methodology.
Conduct statistical analyses per the Statistical Analysis Plan (SAP) and provide insights on results for study reports.
Ensure the integrity of statistical content in CSRs, including sections on sample size calculation, randomization, and methodology.
Perform exploratory and ad-hoc analyses relevant to the study objectives.
Collaborate with the programming team on data definitions, documentation, and quality control.
Represent statistics in cross-functional groups and work with senior leadership to promote quality, operational efficiency, and innovation.

About You:

Experience: Proven experience in clinical trials, preferably within the pharmaceutical industry.
Skills: Strong knowledge of statistical concepts and the ability to perform advanced analyses using SAS, R, or similar languages.
Education: MS or PhD in Statistics or related fields.
Communication: Effective communication in English, both written and oral.

Why Sanofi?

Access to endless growth opportunities within an innovative, global healthcare company.
Competitive rewards package, including comprehensive health benefits and gender-neutral parental leave.
Opportunity to gain international clinical trial experience and contribute to global healthcare progress.

At Sanofi, we celebrate diversity and are committed to providing equal opportunities for all.

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Principal Biostatistician-Clinical Statistics

Job Description

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