Senior Principal Biostatistician

Role Description

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.

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.

Qualifications

• 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.

Requirements

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

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 a 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.

Company Description

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 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.
• 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.
• ClinChoice is an equal opportunity employer, guided by diversity and inclusivity.