Principal Biostatistician Consultant- Remote in US (Oncology)

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.

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
• Who will you be working for?
• About ClinChoice
• Our Company Ethos
• ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
• #LI-TT1 #LI-Remote #Principal#Contract

Benefits

Additional Information

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds.... ClinChoice is searching for an Principal Biostatistician Consultant to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client's counterparts. Job Summary We are seeking an experienced Principal Biostatistician to provide statistical leadership for oncology clinical development programs. This role will support Phase I-III clinical trials and contribute to regulatory submissions while collaborating closely with cross-functional teams.

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