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Associate Director Biostatistics - Remote

7+ years
Not Disclosed
10 Sept. 17, 2024
Job Description
Job Type: 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 of Biostatistics
Location: Remote
Contact: Susan Devine - sdevine@penfieldsearch.com

About the Role:
We are seeking an experienced Associate Director of Biostatistics for a clinical-stage biotech company specializing in Gene Therapy and Rare Diseases. This hands-on role demands a high level of technical expertise and experience in statistical analysis, clinical trial design, and regulatory requirements. You will leverage your knowledge to guide the design and execution of clinical trials across all phases and contribute to the company's strategic objectives.

Key Responsibilities:

  • Statistical Guidance: Provide expert recommendations on statistical issues, including the design, analysis, and interpretation of clinical trials.
  • Trial Design and Analysis: Develop and apply advanced statistical methods for the planning and execution of clinical trials. Ensure methodological rigor and compliance with regulatory standards.
  • Collaboration: Work closely with clinicians, data managers, biostatisticians, statistical programmers, and medical writers to ensure successful trial outcomes.
  • Knowledge Sharing: Maintain and share up-to-date knowledge of statistical methods and innovations. Apply this knowledge creatively to solve problems and meet company goals.
  • Regulatory Experience: Contribute to the preparation and review of regulatory submissions, including NDAs and MAAs.

Qualifications:

  • Education: PhD in Statistics or Biostatistics.
  • Experience: At least 7 years of relevant experience in the pharmaceutical industry, with a strong background in clinical research.
  • Technical Skills: Comprehensive understanding of advanced statistical concepts and techniques applicable to clinical trials.
  • Regulatory Knowledge: Familiarity with pharmaceutical environment and regulatory requirements, including experience with NDAs and MAAs is highly desirable.
  • Interpersonal Skills: Excellent project management, communication, and interpersonal skills. Proven ability to influence and advance innovative statistical methodologies.

Why Apply?
Join a forward-thinking biotech company with a solid track record and a promising pipeline in gene therapy and rare diseases. This role offers an opportunity to make a significant impact on the development of groundbreaking therapies while working in a collaborative and dynamic environment.

To Apply:
Contact Susan Devine at sdevine@penfieldsearch.com for more information or to submit your application.

Equal Opportunity Statement:
Our client is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.