Senior/Principal Statistician Consultant
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Job Description
Senior/Principal Statistician guiding clinical trial design, analysis, and regulatory submissions. Supporting pharmaceutical, biotech, medical device, and consumer health clients at global CRO ClinChoice.
Responsibilities:
- Provide statistical leadership across clinical development programs, from early-phase studies through late-phase clinical trials
- Lead clinical trial design, including endpoint selection, sample size calculations, power analyses, and randomization strategies
- Develop and review clinical study protocols, statistical analysis plans (SAPs), and other statistical documentation
- Oversee statistical analyses and interpretation of clinical trial data to ensure scientific rigor and regulatory compliance
- Provide statistical expertise for regulatory submissions and interactions with health authorities, including the FDA and EMA
- Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Medical Writing teams
- Review statistical outputs, including tables, listings, and figures (TLFs), to ensure accuracy and consistency with analysis plans
- Apply appropriate statistical methodologies to address complex clinical trial design and analysis challenges
- Contribute to clinical study reports (CSRs), integrated summaries of safety and efficacy, and other regulatory documents
- Identify statistical risks and recommend appropriate solutions throughout the clinical development process
- Provide technical guidance and mentorship to statisticians and other team members, as appropriate
Requirements:
- PhD in Statistics, Biostatistics, or a related quantitative discipline; a Master's degree with substantial relevant experience may also be considered
- Significant experience in biostatistics within the pharmaceutical, biotechnology, or clinical research industry
- Strong knowledge of clinical trial design, statistical inference, sample size determination, power calculations, and statistical analysis methodologies
- Proven experience developing and reviewing statistical analysis plans, clinical study protocols, and clinical study reports
- Familiarity with regulatory requirements and guidance applicable to clinical development and statistical analyses
- Experience supporting clinical development programs in oncology, rare diseases, and/or neuroscience
- Experience supporting regulatory submissions and health authority interactions
- Experience with complex clinical trial designs and advanced statistical methodologies
- Proficiency in statistical programming tools such as SAS and/or R
- Strong analytical, problem-solving, communication, and stakeholder-management skills
- Ability to work independently and collaborate effectively with global cross-functional teams
Benefits:
- Professional growth opportunities
- Continuous training and development
- Close management and training
- Equal opportunity employer with a focus on diversity and inclusivity
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