Principal Biostatistician Consultant – Oncology
Job Description:
• Provide statistical leadership for oncology clinical trials across multiple phases (Phase I–III).
• Lead the development of statistical analysis plans (SAPs), protocols, and clinical study reports (CSRs).
• Design and review statistical methodologies for efficacy and safety analyses.
• Oversee analysis datasets (SDTM/ADaM) and TLFs in compliance with CDISC standards.
• Support interim analyses, data monitoring committee (DMC) activities, and adaptive designs.
• Collaborate with clinical development, data management, programming, regulatory, and medical teams.
• Contribute to regulatory submissions (IND, NDA, BLA) and respond to health authority queries (FDA, EMA).
• Provide strategic input on study design, endpoint selection, and sample size calculations.
• Mentor junior statisticians and provide technical guidance.
Requirements:
• PhD or MS in Statistics, Biostatistics, or related field.
• 8+ years (MS) or 6+ years (PhD) of industry experience in biostatistics.
• Strong experience in oncology clinical trials.
• Hands-on experience with survival analysis, time-to-event endpoints, and complex oncology study designs.
• Proficiency in SAS and/or R.
• Strong knowledge of CDISC standards (SDTM, ADaM).
• Experience supporting regulatory submissions.
• Excellent communication and leadership skills.
Benefits:
• Health insurance
• professional development opportunities
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• Provide statistical leadership for oncology clinical trials across multiple phases (Phase I–III).
• Lead the development of statistical analysis plans (SAPs), protocols, and clinical study reports (CSRs).
• Design and review statistical methodologies for efficacy and safety analyses.
• Oversee analysis datasets (SDTM/ADaM) and TLFs in compliance with CDISC standards.
• Support interim analyses, data monitoring committee (DMC) activities, and adaptive designs.
• Collaborate with clinical development, data management, programming, regulatory, and medical teams.
• Contribute to regulatory submissions (IND, NDA, BLA) and respond to health authority queries (FDA, EMA).
• Provide strategic input on study design, endpoint selection, and sample size calculations.
• Mentor junior statisticians and provide technical guidance.
Requirements:
• PhD or MS in Statistics, Biostatistics, or related field.
• 8+ years (MS) or 6+ years (PhD) of industry experience in biostatistics.
• Strong experience in oncology clinical trials.
• Hands-on experience with survival analysis, time-to-event endpoints, and complex oncology study designs.
• Proficiency in SAS and/or R.
• Strong knowledge of CDISC standards (SDTM, ADaM).
• Experience supporting regulatory submissions.
• Excellent communication and leadership skills.
Benefits:
• Health insurance
• professional development opportunities
Apply tot his job
Apply To this Job