Senior Biostatistician

About the role

The Senior Biostatistician (Biostatistician IV) plays a crucial role in supporting the design, conduct, and analysis of clinical studies. They provide advanced statistical expertise, manage projects, and ensure that clinical evidence meets the highest standards for regulatory submissions and scientific publication.

Responsibilities

• 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.

• 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.

• Serve as the Biostatistics representative in core team meetings, setting functional roadmaps and managing stakeholder expectations.

• Manage a portfolio of 3–7 projects simultaneously and take ownership of one specific business or functional area.

• Interpret complex statistical results for cross-functional teams in a clear and actionable manner, considering clinical implications and proactively offering alternative solutions.

• 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.

• Engage with external stakeholders, including regulatory agencies, Principal Investigators (PIs), and Key Opinion Leaders (KOLs) to define requirements, generate deliverables, and gather feedback.

• Partner with Data Management to co-standardize edit specifications, critical variable lists, data structures, and extraction workflows to ensure data integrity and scalability.

• 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.

• Provide guidance and leadership to junior biostatisticians.

• Ensure all activities strictly adhere to Good Clinical Practice (GCP), ISO 14155, and 21 CFR Part 812 regulations.

Qualifications

• 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.