ClinChoice 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.
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

Required Qualifications

MS or PhD in Statistics, Biostatistics, or a related field
There are no specific therapeutic area requirements; however, experience in Oncology, Rare Disease, or Neuroscience would be advantageous.
Strong oral and written communication skills, with the ability to effectively communicate internally and with clients.
Demonstrated understanding and insight in statistics, drug development process, and relevant FDA regulations.
Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially the FDA.

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.