Senior/Principal Statistician Consultant

ClinChoice, a global full-service CRO, is seeking a Senior/Principal Statistician to join their in-house team and support projects across pharmaceutical, biotechnology, medical device, and consumer health companies.

We are looking for an experienced Senior/Principal Statistician Consultant to provide statistical leadership and expertise across clinical development programs within the pharmaceutical industry. The successful candidate will contribute to clinical trial design, statistical methodology, data analysis, and regulatory submissions while collaborating with cross-functional teams to support evidence generation and informed decision-making throughout drug development.

Key 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.

Required Qualifications and Experience

• A 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.