Senior/Principal Statistician Consultant

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

📋 Description

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

• Spearhead the design of clinical trials, including selection of endpoints, calculations for sample size, power analyses, and strategies for randomization.

• Create and evaluate clinical study protocols, statistical analysis plans (SAPs), and additional statistical documentation.

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

• Provide statistical expertise for submissions to regulatory bodies and during interactions with health authorities, including the FDA and EMA.

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

• Review statistical outputs, such as tables, listings, and figures (TLFs), to ensure accuracy and alignment with analysis plans.

• Utilize suitable statistical methodologies to tackle intricate challenges in clinical trial design and analysis.

• Contribute to the preparation of clinical study reports (CSRs), integrated summaries of safety and efficacy, and other regulatory documents.

• Identify potential statistical risks and suggest effective solutions throughout the clinical development continuum.

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

⛳️ Requirements

• PhD in Statistics, Biostatistics, or a related quantitative field; a Master's degree with significant relevant experience may also be considered.

• 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 methodologies.

• Proven track record in developing and reviewing statistical analysis plans, clinical study protocols, and clinical study reports.

• Knowledge of regulatory requirements and guidelines pertinent to clinical development and statistical analyses.

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

• Familiarity with regulatory submissions and interactions with health authorities.

• Experience with complex clinical trial designs and advanced statistical methodologies.

• Proficient in statistical programming software such as SAS and/or R.

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

• Capability to work independently as well as collaboratively within global cross-functional teams.

🏝️ Benefits

• Opportunities for professional growth.

• Ongoing training and development.

• Supportive management and training environment.

• Equal opportunity employer committed to diversity and inclusivity.