Senior/Principal Statistician with focus on Immunology studies_FTE-Remote
About The Position
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds... ClinChoice is currently recruiting for a Senior/Principal Statistician to focus on Immunology studies to join our team in a permanent position—an exciting opportunity to lead impactful statistical strategy in a dynamic environment. Job Summary We are seeking a highly skilled Senior or Principal Statistician to support and lead statistical activities for clinical trials, with a strong focus on Immunology studies. This role requires hands-on statistical expertise, strong communication skills, and the ability to independently lead projects while collaborating closely with cross-functional teams.
Requirements
- MS or PhD in Statistics, Biostatistics, or a related field
- Strong experience in Immunology clinical studies (required)
- Proven ability to lead projects and studies independently
- 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
Nice To Haves
- Experience leading Phase II–III clinical trials
- Prior interaction with regulatory agencies
- Experience mentoring junior statisticians or programmers
Responsibilities
- Lead and provide statistical support for clinical studies, primarily within Immunology 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
