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Sr. Biostatistician

15+ years
Preferred by Comapny
11 Nov. 26, 2024
Job Description
Job Type: Full Time Education: Master’s in Statistics/Biostatistics 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 Description: Senior Biostatistician – Clinical Trials

Industry: Pharmaceuticals | Experience: 15+ Years | Education: Master’s in Statistics/Biostatistics

Key Responsibilities:

  • Design statistically sound clinical studies (premarketing & postmarketing), including sample size calculations to balance validity and efficiency.
  • Interpret scientific literature for numerical accuracy and adapt findings for study designs and decision-making.
  • Conduct trial simulations to optimize endpoints, methodologies, and designs.
  • Develop and review statistical sections of protocols, SAPs, randomization plans, and data management documents.
  • Oversee statistical analysis, including programming, validation, and reporting of trial outcomes.
  • Collaborate with teams to resolve statistical issues and guide regulatory submissions.
  • Perform interim analyses, sample size re-estimations, and blinded data reviews to finalize analysis populations.
  • Prepare comprehensive statistical reports and presentations for decision-making and regulatory interactions.
  • Ensure compliance with CDISC standards (SDTM, ADaM) and lead TFL (Tables, Listings, Figures) reviews.

Mandatory Skills:

  • Expertise in SAS, R, and statistical software.
  • Strong foundation in statistical theory, modeling, and data management for clinical trials.
  • Proficiency in linear/mixed models, logistic regression, non-parametric statistics, and longitudinal data analysis.
  • Familiarity with therapy areas, disease treatment options, technology platforms, and clinical development basics.

About You:

You bring 15+ years of pharmaceutical industry expertise, specializing in clinical trial design and analysis. With a deep understanding of biostatistics and regulatory requirements, you excel in delivering actionable insights and fostering collaboration across clinical and regulatory teams.


Join us to shape the future of clinical research with innovative designs and impactful analysis!