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 SummaryWe 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
Skills Required
- 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 and time-to-event endpoints
- Proficiency in SAS and/or R
- Strong knowledge of CDISC standards (SDTM, ADaM)
- Experience supporting regulatory submissions
- Excellent communication and leadership skills
ClinChoice Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ClinChoice and has not been reviewed or approved by ClinChoice.
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Flexible Benefits — Flexible arrangements, including telecommuting and flextime with no core hours in some regions, are highlighted for many roles. Feedback suggests flexibility is commonly available but depends on role and location.
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Leave & Time Off Breadth — Vacation, personal, and sick days are part of the core package, with some markets granting paid leave from the date of hire. Feedback suggests time off is standard-to-decent across locations, though specifics vary.
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Healthcare Strength — Health coverage is positioned as a core benefit, with some accounts describing overall benefits as full or good. In the U.S., healthcare sits within a conventional CRO package alongside medical, dental, and vision.
ClinChoice Insights
What We Do
ClinChoice is a global full-service Contract Research Organization (CRO) specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies, aiming to accelerate the development and commercialization of innovative drugs and devices.
