Clinchoice Inc.

Principal Biostatistician for inhouse project (Permanent role)

United States · Principal

Sponsorship not specifiedDetected 6 days ago

GCPComputer VisionStatisticsComplianceClinical TrialsFDA RegulatoryMedical DevicesSASCommunicationMentoringBiostatistics

About the role

ClinChoice is a global full-service CRO committed to professional growth and a quality-driven "one-team" culture.
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.

Lead and provide statistical support for clinical studies, primarily within Immunology or any therapeutic areas
Act as the lead statistician on assigned studies, overseeing statistical strategy and deliverables
Collaborate with cross-functional teams including Clinical, Programming, Data Management, and Regulatory
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.

Experience leading Phase II-III clinical trials
Prior interaction with regulatory agencies
Experience mentoring junior statisticians or programmers
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

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.
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
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

This listing is sourced directly from Clinchoice Inc.'s careers page and normalized into a canonical job model.