Principal Biostatistician Consultant_Oncology_ Remote in US
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.
Key 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.
Qualifications
- 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.
Preferred Qualifications
- 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? About ClinChoice 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 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. 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 Apply tot his job Apply To this Job