Senior Principal Biostatistician/Senior Manager, Biostatistician - Study Lead; Oncology; Remote
Northern, Floyd County, Kentucky, USA
Listed on 2026-09-12
-
IT/Tech
Data Scientist, Data Analyst
United States
Clin Choice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a
Principal Statistician
to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes.
We are seeking a highly skilled
Principal Statistician
to lead statistical activities for clinical trials. This role requires hands‑on statistical expertise, strong communication skills, and the ability to independently lead projects while collaborating closely with cross-functional teams.
Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!
Key Responsibilities- Lead and provide statistical support for clinical studies, primarily within Oncology
- Act as the
lead statistician
on assigned studies, overseeing statistical strategy and deliverables - Author and review key statistical documents, including:
- Statistical Analysis Plans (SAPs)
- Analysis Database Specifications (ADS)
- Statistical sections of clinical study reports
- Review and interpret analysis outputs, ensuring accuracy, quality, and regulatory compliance
- Collaborate with cross-functional teams including Clinical, Programming, Data Management, and Regulatory
- Provide guidance and oversight to statistical programmers as needed
- Communicate statistical concepts, results, and risks clearly to both technical and non-technical stakeholders
- Ensure adherence to regulatory standards (FDA, ICH, GCP) and company SOPs
MS or PhD in Statistics, Biostatistics, or a related field
Strong experience in Oncology studies
Hands‑on experience writing:
Statistical Analysis Plans (SAPs)
Analysis Database Specifications
Reviewing and interpreting analysis results
SAS programming skills required (hands‑on or strong working knowledge)
Experience working in a CRO and/or pharmaceutical/biotech environment
Preferred QualificationsExperience leading Phase II–III clinical trials
Prior interaction with regulatory agencies
Experience mentoring junior statisticians or programmers
About Clin ChoiceClin Choice 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 EthosOur 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 Clin Choice 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.
Clin Choice 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.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).