Clinchoice Senior Principal Biostatistician leads statistical activities for clinical trials primarily in Oncology. This role involves authoring key statistical documents and collaborating with cross-functional teams to ensure regulatory compliance.
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
Qualification
MS or PhD in StatisticsStrong experience in Oncology studiesHands-on experience writingStatistical Analysis Plans (SAPs)Analysis Database SpecificationsThe Application ProcessOnce you have submitted your CVWho will you be working for?About ClinChoice
Required
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)
Excellent written and verbal communication skills
Experience working in a CRO and/or pharmaceutical/biotech environment
Preferred
Experience leading Phase II–III clinical trials
Prior interaction with regulatory agencies
Experience mentoring junior statisticians or programmers
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.