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Principal Biostatistician - India, Remote

7+ years
Preferred by Comapny
11 Nov. 25, 2024
Job Description
Job Type: Remote Education: Ph.D. in Statistics or a related discipline, or Master’s with substantial experience. 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

Role: Principal Biostatistician

The Principal Biostatistician operates independently, addressing complex clinical trial projects with significant regulatory implications. Recognized as an expert both internally and externally, this role provides leadership in statistical methods and guidance across studies and regulatory interactions.


Key Responsibilities

Operational Execution

  1. Statistical Support:

    • Offer comprehensive statistical expertise in trial design, protocol, and case report form (CRF) development.
    • Perform sample size calculations, randomization list generation, and contribute to statistical methodology in study protocols.
  2. Document Leadership:

    • Lead the production and quality control of randomization, statistical analysis plans, and reports.
    • Prepare statistical sections for integrated clinical reports and related documentation.
  3. Data Monitoring Committees (DMC):

    • Develop DMC charters and analysis plans.
    • Serve as a non-voting independent statistician for DMC data review and analysis.

Business Development

  • Support study design considerations during client and internal discussions.
  • Provide sample size scenarios and statistical insights for proposals and budgets.
  • Actively participate in bid defense meetings, representing statistical expertise.

General Activities

  • Understand regulatory requirements for therapeutic areas and statistical analyses.
  • Apply and train teams in advanced and novel statistical methods.
  • Contribute to internal and external training programs on statistical best practices.
  • Review publications, clinical study reports, and position papers based on current statistical standards.
  • Actively participate in client and regulatory meetings to discuss analysis concepts and present study results.

Skills

  • Exceptional analytical and project management abilities.
  • Attention to detail and a professional demeanor.
  • Expertise in advanced statistical techniques with the ability to explain and interpret results.
  • In-depth knowledge of drug development guidelines, GCP, and ICH statistical principles.
  • Proficiency in SAS programming.
  • Strong mentoring and leadership skills.
  • Awareness of business development and client interaction needs.

Knowledge and Experience

  • Education:

    • Ph.D. in Statistics or a related discipline, or Master’s with substantial experience.
  • Experience:

    • Minimum 7+ years of experience in statistical analysis for clinical trials.
    • Familiarity with pharmacokinetic data is advantageous.
  • Language:

    • Proficiency in written and spoken English, with additional competency in local languages as required.

The Principal Biostatistician role is ideal for a seasoned professional eager to influence statistical strategy, regulatory compliance, and the successful delivery of clinical trials. This position combines statistical expertise with business acumen and leadership to drive impactful results.