Principal Biostatistician for inhouse project (Permanent role)
ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Clinical Project Manager II 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 Immunology or any therapeutic areas
- 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
- Strong experience in Immunology or any TA clinical 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 Qualifications
- 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. Our Company Ethos 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 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. ClinChoice 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. #LI-TT1 #LI-Remote #Principal#Permanent