Senior/Principal Statistician Consultant

This is a fully remote position, open to applicants in Europe.

📋 Description

• Deliver statistical leadership throughout clinical development initiatives, from early-phase research to late-stage clinical trials.

• Direct the design of clinical trials, which includes selecting endpoints, calculating sample sizes, conducting power analyses, and devising randomization strategies.

• Create and evaluate clinical study protocols, statistical analysis plans, and various other statistical documentation.

• Supervise statistical analyses and the interpretation of clinical trial data to ensure scientific integrity and adherence to regulatory standards.

• Offer statistical expertise for regulatory submissions and engage with health authorities, including the FDA and EMA.

• Collaborate with teams in Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Medical Writing.

• Assess statistical outputs, including tables, listings, and figures, ensuring accuracy and alignment with analysis plans.

• Utilize appropriate statistical methods to address complex challenges in clinical trial design and analysis.

• Contribute to clinical study reports, integrated summaries of safety and efficacy, and other regulatory documentation.

• Recognize statistical risks and propose solutions throughout the clinical development process.

• Provide technical guidance and mentorship to statisticians and other team members.

⛳️ Requirements

• PhD in Statistics, Biostatistics, or a related quantitative field; a Master's degree accompanied by considerable relevant experience may also be acceptable.

• Extensive experience in biostatistics within the pharmaceutical, biotechnology, or clinical research sectors.

• Strong understanding of clinical trial design, statistical inference, sample size determination, power calculations, and statistical analysis techniques.

• Demonstrable experience in developing and reviewing statistical analysis plans, clinical study protocols, and clinical study reports.

• Familiarity with the regulatory requirements and guidelines relevant to clinical development and statistical analyses.

• Experience supporting clinical development programs in oncology, rare diseases, and/or neuroscience.

• Background in assisting with regulatory submissions and interactions with health authorities.

• Experience with intricate clinical trial designs and advanced statistical techniques.

• Proficiency in statistical programming tools such as SAS and/or R.

• Excellent analytical, problem-solving, communication, and stakeholder management skills.

• Ability to work autonomously as well as collaboratively with global cross-functional teams.

🏝️ Benefits

• Opportunities for professional growth.

• Ongoing training and development.

• Comprehensive management and training to uphold a highly qualified workforce.

• Commitment to equal opportunity, diversity, and an inclusive culture.