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Associate Director Biostatistics - Remote

7+ years
Not Disclosed
10 Nov. 6, 2024
Job Description
Job Type: Full Time Remote 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: Associate Director Biostatistics
Location: Remote
Contact: Susan Devine - sdevine@penfieldsearch.com


About the Job:

Our client, a clinical-stage biotech company specializing in Gene Therapy and Rare Disease treatments, is looking for an experienced Associate Director of Biostatistics. This hands-on role requires an expert biostatistician to provide strategic guidance on statistical issues, clinical trial design, and analysis for studies across all phases. You will play a crucial role in shaping the direction of clinical trials, ensuring alignment with regulatory requirements, and developing innovative statistical methodologies that advance the company’s research objectives.

You will be part of a collaborative team working closely with clinicians, data managers, biostatisticians, statistical programmers, and medical writers. This position offers the opportunity to leverage your deep expertise and make significant contributions to the design, conduct, and analysis of clinical trials while staying at the forefront of statistical techniques.


Key Responsibilities:

  • Provide statistical recommendations for the design and analysis of clinical trials across all phases.
  • Develop, maintain, and share knowledge of advanced statistical methods suitable for clinical research.
  • Collaborate with cross-functional teams including clinicians, medical writers, and statisticians to ensure trials are well-designed and executed.
  • Ensure compliance with pharmaceutical regulatory requirements and industry standards.
  • Contribute to the advancement of statistical methodologies to enhance clinical trial design and data analysis.
  • Stay current with new statistical techniques and tools, applying them creatively to meet company objectives.

Qualifications:

  • PhD in Statistics or Biostatistics with at least 7 years of relevant experience in the pharmaceutical or biotechnology industry.
  • Strong understanding of advanced statistical techniques and their application in clinical trials.
  • Familiarity with pharmaceutical regulations, including experience with NDAs and MAAs, is highly desired.
  • Excellent project management skills, with the ability to influence teams and drive results.
  • Outstanding interpersonal and communication skills, with the ability to collaborate effectively across multidisciplinary teams.

If you are an experienced biostatistician with a passion for Gene Therapy and Rare Disease research, we encourage you to apply and contribute to groundbreaking work in this innovative biotech environment.

Apply Today!