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Jobs/Principal Role/ClinChoice - Principal Biostatistician Consultant (Oncology) Remote
ClinChoice

ClinChoice - Principal Biostatistician Consultant (Oncology) Remote

United States2w ago
In OfficePrincipalNAMedical DevicesPharmaceuticalsPrincipalCROSASClinical TrialsTeam ManagementReportingCRO

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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. • Experience with adaptive designs and Bayesian methods. • Prior experience interacting with regulatory agencies. • Experience in immuno-oncology or hematology oncology. • The Application Process • Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. • Who will you be working for? • ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. • Our Company Ethos • Our Company Ethos • Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

Responsibilities

• 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.

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