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Principal Biostatistician (Oncology - Clinical Trials)

Posted 2024-11-09

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💎 Seniority level: Principal, 10+ years with Master’s, 7+ years with PhD

📍 Location: US, Canada

🔍 Industry: Biotechnology/Pharmaceuticals

🏢 Company: Precision Medicine Group

⏳ Experience: 10+ years with Master’s, 7+ years with PhD

🪄 Skills: LeadershipProject ManagementData AnalysisSAS EGProject CoordinationCross-functional Team LeadershipData analysisCommunication SkillsAnalytical SkillsCollaboration

Requirements:
  • Master's degree or equivalent in Statistics, Biostatistics, or related field with 10+ years experience, or PhD with 7+ years experience.
  • Experience with SAS.
  • Knowledge of ICH guidelines, CDISC data structures, and FDA guidelines.
  • Advanced statistical concepts understanding.
  • Preferred experience with Oncology and rare diseases, late phase submissions, and consulting on study design.
Responsibilities:
  • Generate and verify randomization schedules.
  • Develop and review statistical methods of clinical study protocols.
  • Provide and verify sample size calculations and perform advanced calculations.
  • Author and review statistical analysis plans.
  • Generate analysis datasets, tables, figures, and listings using SAS.
  • Conduct quality control for statistical SAS programs and documents.
  • Serve as a consultant to global staff with regional understanding.
  • Provide statistical analysis for Data Monitoring Committees.
  • Interact with sponsors, project managers, and vendors.
  • Lead statistical activities, perform budget health reviews, and oversee projects.
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🔥 Principal Biostatistician (Oncology - Clinical Trials)
Posted 2024-11-09

📍 US, Canada

🧭 Full-Time

💸 133000 - 180000 USD per year

🔍 Pharmaceutical/Biotech

🏢 Company: Precision for Medicine

  • Master's degree or equivalent in Statistics, Biostatistics, or related field with 10+ years of experience.
  • PhD degree in Statistics, Biostatistics, or related field with 7+ years of experience.
  • Experience with SAS.
  • Knowledge of ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
  • Advanced statistical concepts and techniques.
  • Preferred experience with Oncology and rare diseases.
  • Broad experience with late phase and/or submissions.
  • Experience consulting on study design.

  • Generate and/or verify randomization schedules.
  • Develop and review statistical methods for clinical study protocols including complex study designs.
  • Provide and/or verify sample size calculations and perform advanced calculations like adaptive design.
  • Author and review statistical analysis plans, including table, figure, and listing shells.
  • Generate analysis datasets, tables, figures, and listings using SAS.
  • Perform quality control for SAS programs and other study documents.
  • Serve as a biostatistical consultant internally and externally.
  • Provide statistical analysis and reports to Data Monitoring Committees.
  • Work with sponsors and project managers on statistics-related project components.
  • Lead all statistical activities for study within timelines.

LeadershipProject ManagementData AnalysisProduct ManagementSAS EGProject CoordinationCross-functional Team LeadershipData analysisCommunication SkillsAnalytical SkillsCollaboration

Posted 2024-11-09
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