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Associate Director, Biostatistics

Posted 2024-10-21

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💎 Seniority level: Director, A minimum of 8 years’ experience in progressive and relevant clinical trial experience

💸 Salary: 185000 - 205000 USD per year

🔍 Industry: Biotechnology

🏢 Company: Apogee Therapeutics

🗣️ Languages: English

⏳ Experience: A minimum of 8 years’ experience in progressive and relevant clinical trial experience

Requirements:
  • PhD in statistics strongly preferred; MS in statistics, biostatistics, or mathematics with relevant experience considered.
  • A minimum of 8 years’ experience in clinical trials.
  • Experience managing CROs and other data vendors.
  • Advanced knowledge in statistical methods and analysis.
  • Ability to communicate complex statistical information to non-statisticians.
  • Proficiency in SAS or R, CDISC standards, and ICH guidelines.
Responsibilities:
  • Acting as the statistical lead for clinical studies.
  • Providing statistical support on study design and execution.
  • Partnering with cross-functional teams to ensure statistical integrity.
  • Contributing to regulatory submissions and communications with authorities.
  • Overseeing vendor/CRO teams, including verifying results and conducting analyses.
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🔥 Associate Director, Biostatistics
Posted 2024-11-07

📍 USA

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🏢 Company: Apellis

  • PhD in Statistics, Biostatistics, or Mathematics with a minimum of 5 years (8 years for master’s degree) of post-graduate experience in clinical trials.
  • Experience in managing biostatistical services from CROs.
  • Acted as product lead statistician in cross-functional discussions.
  • Adept in study-level work including authoring SAPs.
  • Knowledge of ICH guidelines and FDA/EMA guidance.
  • Solid understanding of statistical methods preferred (longitudinal analysis, Bayesian methods, adaptive design, simulations).
  • Communication skills to translate statistical concepts into strategies.
  • Proficiency in SAS and R, familiarity with CDISC including SDTM and ADaM.

  • Act as statistical lead for multiple clinical studies and clinical development programs.
  • Provide leadership in designing studies and selecting statistical methods.
  • Participate in regulatory interactions and submissions.
  • Contribute to biometrics standards and training.
  • Author/review statistical sections in protocol, SAP, and DMC charter.
  • Review study documentations and participate in study meetings.
  • Oversee statistical work by CROs, ensuring quality deliverables.
  • Conduct independent analyses and propose novel methodologies.
  • Ensure statistical integrity of deliverables and provide methodological input.
  • Author/review regulatory documents or scientific publications.

LeadershipData AnalysisSAPStrategyData analysisResource Planning

Posted 2024-11-07
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