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Primary Function of Position
As a key member of the Clinical Affairs department, the Senior Biostatistician (Biostatistician IV) provides advanced statistical expertise to support the design, conduct, and analysis of clinical studies, ranging from early pre-market to post-market evidence generation. The Biostatistician IV is the statistical subject matter expert working in cross-functional teams, managing roadmaps and priorities to ensure timely and high quality delivery of results. This role serves as a nearly independent statistical lead, providing technical leadership by improving analysis processes, mentoring junior staff, and managing a diverse project portfolio to ensure that clinical evidence meets the highest standards for regulatory submissions and scientific publication.
Roles & Responsibilities
Study Design & Protocol Development: Lead the writing of statistical sections for complex clinical protocols with limited supervision, ensuring robust study designs, hypothesis tests, power analyses, and sample size justifications.
Data Analysis: Utilize appropriate and robust statistical and programming methodology in the analysis of clinical trial data, including complex and advanced methods as needed, ensuring high-quality results for regulatory submissions and scientific publications.
Clinical Operations Roadmap: Serve as the Biostatistics representative in core team meetings, setting functional roadmaps and managing stakeholder expectations.
Portfolio Management: Manage a portfolio of 3–7 projects simultaneously and take ownership of one specific business or functional area.
Team Communication: Interpret complex statistical results for cross-functional teams in a clear and actionable manner, considering clinical implications and proactively offering alternative solutions.
Scientific Literature and Evidence Generation: Independently search and learn from scientific literature. Write complete methods, results, and analysis interpretation sections with supervision for regulatory submissions, compliance, scientific journals, and medical conferences. Explore novel biostatistical & programming methodology applications.
External Engagement: Engage with external stakeholders, including regulatory agencies, Principal Investigators (PIs), and Key Opinion Leaders (KOLs) to define requirements, generate deliverables, and gather feedback.
Data Management Support: Partner with Data Management to co-standardize edit specifications, critical variable lists, data structures, and extraction workflows to ensure data integrity and scalability.
Process Improvement: Improve standardization and quality control of analysis pipelines across projects, ensuring high-quality results for regulatory submissions and scientific publications. Improve and implement SOPs and WIs for Statistical Analysis Plans (SAPs) and mock Tables, Listings, and Figures (TLFs), balancing flexibility and consistency across studies.
Mentorship: Provide guidance and leadership to junior biostatisticians.
Regulatory Compliance: Ensure all activities strictly adhere to Good Clinical Practice (Google Cloud Platform), ISO 14155, and 21 CFR Part 812 regulations.
Skills, Experience, Education, & Training
Minimum Degree: Master’s (MS) or Ph.D. in Biostatistics or Statistics.
Professional Experience: Minimum of 6 years of experience with an MS, or 3 years with a Ph.D..
Industry Experience: Minimum of 4 years of experience in clinical trials, surgical medical device clinical research strongly preferred.
Statistical Methods: Proven expertise in advanced and complex statistical methodologies, including experience with adaptive designs or Bayesian methods.
Programming: Mastery of R preferred, SAS and Python also considered; ability to write clean, functional, modular code for a team development environment and train junior team members in best practices.
Independence & Leadership: Demonstrated ability to work nearly independently while providing functional mentorship to junior biostatisticians.
External Reputation: Track record of strong professional relationships within the external scientific (biostatistics, medical devices, clinical trials) and/or regulatory community.
Communication: Excellent verbal and written communication, teamwork, and interpersonal skills with both technical and non-technical constituents.
Logistics
Primary Function of Position
As a key member of the Clinical Affairs department, the Senior Biostatistician (Biostatistician IV) provides advanced statistical expertise to support the design, conduct, and analysis of clinical studies, ranging from early pre-market to post-market evidence generation. The Biostatistician IV is the statistical subject matter expert working in cross-functional teams, managing roadmaps and priorities to ensure timely and high quality delivery of results. This role serves as a nearly independent statistical lead, providing technical leadership by improving analysis processes, mentoring junior staff, and managing a diverse project portfolio to ensure that clinical evidence meets the highest standards for regulatory submissions and scientific publication.
Roles & Responsibilities
Study Design & Protocol Development: Lead the writing of statistical sections for complex clinical protocols with limited supervision, ensuring robust study designs, hypothesis tests, power analyses, and sample size justifications.
Data Analysis: Utilize appropriate and robust statistical and programming methodology in the analysis of clinical trial data, including complex and advanced methods as needed, ensuring high-quality results for regulatory submissions and scientific publications.
Clinical Operations Roadmap: Serve as the Biostatistics representative in core team meetings, setting functional roadmaps and managing stakeholder expectations.
Portfolio Management: Manage a portfolio of 3–7 projects simultaneously and take ownership of one specific business or functional area.
Team Communication: Interpret complex statistical results for cross-functional teams in a clear and actionable manner, considering clinical implications and proactively offering alternative solutions.
Scientific Literature and Evidence Generation: Independently search and learn from scientific literature. Write complete methods, results, and analysis interpretation sections with supervision for regulatory submissions, compliance, scientific journals, and medical conferences. Explore novel biostatistical & programming methodology applications.
External Engagement: Engage with external stakeholders, including regulatory agencies, Principal Investigators (PIs), and Key Opinion Leaders (KOLs) to define requirements, generate deliverables, and gather feedback.
Data Management Support: Partner with Data Management to co-standardize edit specifications, critical variable lists, data structures, and extraction workflows to ensure data integrity and scalability.
Process Improvement: Improve standardization and quality control of analysis pipelines across projects, ensuring high-quality results for regulatory submissions and scientific publications. Improve and implement SOPs and WIs for Statistical Analysis Plans (SAPs) and mock Tables, Listings, and Figures (TLFs), balancing flexibility and consistency across studies.
Mentorship: Provide guidance and leadership to junior biostatisticians.
Regulatory Compliance: Ensure all activities strictly adhere to Good Clinical Practice (Google Cloud Platform), ISO 14155, and 21 CFR Part 812 regulations.
Skills, Experience, Education, & Training
Minimum Degree: Master’s (MS) or Ph.D. in Biostatistics or Statistics.
Professional Experience: Minimum of 6 years of experience with an MS, or 3 years with a Ph.D..
Industry Experience: Minimum of 4 years of experience in clinical trials, surgical medical device clinical research strongly preferred.
Statistical Methods: Proven expertise in advanced and complex statistical methodologies, including experience with adaptive designs or Bayesian methods.
Programming: Mastery of R preferred, SAS and Python also considered; ability to write clean, functional, modular code for a team development environment and train junior team members in best practices.
Independence & Leadership: Demonstrated ability to work nearly independently while providing functional mentorship to junior biostatisticians.
External Reputation: Track record of strong professional relationships within the external scientific (biostatistics, medical devices, clinical trials) and/or regulatory community.
Communication: Excellent verbal and written communication, teamwork, and interpersonal skills with both technical and non-technical constituents.
Logistics