As a Principal Biostatistician, you will lead statistical design and analysis for a clinical registry project, ensuring robust evidence generation and compliance, while collaborating with clinicians and developing impactful research findings.
Work Flexibility: Remote or Hybrid or Onsite
As a Principal Biostatistician, you will play a critical role in shaping real-world evidence (RWE) strategies across the organization. You will lead statistical design and analysis for our clinical registry project—a cornerstone initiative for understanding long-term clinical outcomes. This role partners closely with surgeons, clinical experts, and cross-functional teams to generate high-quality evidence, publish impactful research, and present findings at scientific meetings.
What You Will Do
- Lead the statistical analysis and methodological development for the clinical registry project, ensuring robust evidence generation from registry data.
- Partner with surgeons and clinical experts to define study questions, interpret results, and co-develop high-impact scientific outputs.
- Drive the development and authorship of manuscripts, abstracts, and presentations based on registry analyses for peer-reviewed journals and international conferences.
- Provide statistical leadership in study design, analysis planning, and reporting for registry-based studies and other RWE initiatives across the portfolio.
- Advise on advanced methods for real-world data, including causal inference, survival and longitudinal modelling, and handling of complex registry datasets.
- Ensure compliance with regulatory standards, industry guidelines, and best practices for RWE study conduct.
- Represent the organization externally with academic collaborators, professional societies, and regulatory/payer bodies.
- Develop statistical analysis plans, coordinate and perform data analysis and validation as necessary, and provide data interpretation.
- Stay current with new developments in statistics, SAS programming, and regulatory guidance through literature review, conference attendance, etc.
- Perform analyses; inputs to the statistical section of the study report. Provide statistical insight into interpretation and discussion of study results.
- Develop and test SAS programs to generate data sets, tables, listings, and graphs.
What You Need
- MS in Statistics, Biostatistics, Epidemiology, or related quantitative discipline with 8+ years of experience or PhD with 5+ years of experience.
- Expertise in registry-based research and real-world data sources.
- Strong proficiency in statistical programming (SAS, R, or Python).
- Knowledge of regulatory guidelines (FDA/CFR; ISO14155).
- Proven ability to influence study strategy and regulatory/payer discussions.
- Excellent scientific writing and presentation skills with a track record of publications.
- SAS proficiency including use of a variety of statistical procedures, e.g., nonparametric analysis, linear and non-linear models, categorical data and survival analysis.
Preferred Qualifications:
- Experience supporting publication of analysis results (abstracts, posters, manuscripts).
- Advanced knowledge of registry design and analysis.
- Ability to explain statistical concepts to non-statisticians and collaborate effectively.
- Strong organizational and time management skills.
- $ 138,700.00 - 226,900.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.
Top Skills
Python
R
SAS
Similar Jobs
Artificial Intelligence • Fintech • Insurance • Marketing Tech • Software • Analytics
The Product Owner II oversees feature prioritization for the Agile team, collaborates with stakeholders, and drives AI innovation in underwriting risk assessment.
Top Skills:
AgileAIAnalyticsData ScienceMachine Learning
Information Technology • Productivity • Software • Infrastructure as a Service (IaaS)
As a Localization Engineer, you will enhance localization processes, manage translations, resolve issues, and ensure product quality across engineering and localization teams.
Top Skills:
Computer-Assisted Translation ToolsPythonTransportation Management System
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
The Sr Director Rare Hematology Integration Lead develops and executes evidence generation strategies for Rare Hematology, collaborating with various teams and external partners, focusing on patient care and medical evidence needs.
Top Skills:
Ai AlgorithmsDigital HealthPfizer Systems
What you need to know about the Boston Tech Scene
Boston is a powerhouse for technology innovation thanks to world-class research universities like MIT and Harvard and a robust pipeline of venture capital investment. Host to the first telephone call and one of the first general-purpose computers ever put into use, Boston is now a hub for biotechnology, robotics and artificial intelligence — though it’s also home to several B2B software giants. So it’s no surprise that the city consistently ranks among the greatest startup ecosystems in the world.
Key Facts About Boston Tech
- Number of Tech Workers: 269,000; 9.4% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Thermo Fisher Scientific, Toast, Klaviyo, HubSpot, DraftKings
- Key Industries: Artificial intelligence, biotechnology, robotics, software, aerospace
- Funding Landscape: $15.7 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Summit Partners, Volition Capital, Bain Capital Ventures, MassVentures, Highland Capital Partners
- Research Centers and Universities: MIT, Harvard University, Boston College, Tufts University, Boston University, Northeastern University, Smithsonian Astrophysical Observatory, National Bureau of Economic Research, Broad Institute, Lowell Center for Space Science & Technology, National Emerging Infectious Diseases Laboratories