2027 Hiring Opportunities – Senior/Principal Statistician Consultant (Remote in
Level inferred from job title
Job description
A Senior/Principal Statistician consultant role providing statistical leadership across clinical development programs for pharmaceutical, biotechnology, medical device, and consumer health clients. The role covers trial design, statistical methodology, data analysis, and regulatory submissions.
At a glance
- Employment
- Contract · Independent contractor
- Work mode
- Remote
What you'll do
- 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.
What we're looking for
- 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.
Your team
in-house team
In-house team supporting projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes.
How to get hired
- 1Submit CV and receive an acknowledgement.
- 2Phone interview as the first step for candidates with the required experience.
Apply
Direct apply at ClinChoice
Opens the job posting at ClinChoice
About ClinChoice
Global full-service CRO specializing in clinical development and functional solutions
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.
Mission
To contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices
Key facts
- over 4,000 professionals
- Contract Research Organization (CRO)
- Over 28 years of proven high-quality delivery and results across all our services
- Over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific
- Below industry average turnover rates
What they value
- Diversity and inclusivity
- Continuous training
- Close management and training to develop and maintain highly-qualified personnel