Principal Biostatistician, Clinical Trials

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

📋 Description

• Mentor and provide guidance while reviewing various analyses from the proposal stage through the entire project lifecycle.

• Utilize statistical knowledge to develop complex analytical strategies and implement them using efficient programming techniques (software: SAS, R).

• Share expertise by contributing to analysis plans, protocol designs, statistical reports, and the statistical sections of clinical documents.

• Prioritize quality by reviewing analysis datasets and ensuring quality control across all types of statistical analysis deliverables.

• Coach and mentor junior department members to enhance their skills and professional growth.

• Improve efficiencies by creating and updating departmental standard operating procedures (SOPs) and work instructions.

• Conduct advanced statistical analyses and provide insights for statistical reports.

• Explore innovative methods for designing and analyzing clinical research studies.

• Serve as the primary statistician for assigned projects from the initial protocol design through to final submissions to regulatory authorities.

• Review and give feedback on case report forms (CRFs), database validation checks, and CRF completion guidelines.

• Generate randomization schedules and oversee blinding and unblinding processes.

• Create and evaluate Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs) as well as table, listing, and figure (TLF) shells when necessary.

• Develop the statistical methods and results sections for statistical reports, clinical study reports (CSR), and manuscripts.

⛳️ Requirements

• PhD in a relevant field with over 5 years of experience in statistical design and analysis of clinical or biomedical studies, or a Master’s degree in a relevant field with more than 8 years of experience.

• Comprehensive knowledge and experience in clinical trial methodologies.

• Familiarity with clinical data management processes and tools (Medidata Rave and Veeva preferred).

• Proven understanding of fundamental statistical concepts and methodologies.

• Established knowledge of research study design methods, along with independent problem-solving and decision-making abilities, as well as principles, concepts, methods, and standards of statistical analyses.

• Ability to articulate statistical concepts to non-statisticians to improve their comprehension of the analytical methods.

• Proficiency in statistical methods used for designing and evaluating clinical trial outcomes.

• Strong research and analytical capabilities, including a general understanding of scientific and therapeutic research.

• Advanced analytical proficiency, especially with SAS.

🏝️ Benefits

• Comprehensive medical, dental, vision, life, and disability insurance, along with accident, critical illness, hospital, well-being, legal, identity theft, and pet benefits.

• Retirement plans.

• Paid time off and holidays.

• Leave and incentive programs.