Insulet Corporation · 3 hours ago
Biostatistician Manager, Clinical Affairs (Hybrid)
Massachusetts, United States
Full-time
Hybrid
Senior Level
$123K/yr - $184K/yrInsulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes. The Biostatistician Manager role will lead the biostatistics team, providing expert statistical support for clinical studies and ensuring compliance with regulatory requirements.
Health CareMedicalMedical Device
Responsibilities
Lead and manage the biostatistics team, providing guidance and mentorship to junior biostatisticians
Develop and implement statistical methodologies for sample size calculations and power analysis
Generation of randomization schedules
Order, collate and interpret large volumes of diverse data and perform exploratory and confirmatory statistical analysis for studies
Manage various datasets, determine summary statistics, conduct hypotheses testing, estimate statistical models, report formats and other analysis considerations
Design and conduct complex statistical analyses for clinical studies, RWE, and other data needs
Prepare statistical analysis plans including development of well-presented mock-up displays for tables, listings, and figures
Review and provide input to study protocols, and clinical study reports
Collaborate with cross-functional teams, including Regulatory Affairs, R&D, ADO, and Marketing, to ensure robust statistical support for product validation and claims
Ensure compliance with regulatory requirements and industry standards for statistical practices
Present findings and statistical insights to stakeholders, including senior management and regulatory bodies and effectively communicate statistical concepts
Stay updated with the latest advancements in biostatistics and medical device regulations
Deliver special projects / ad-hoc reporting as needed
Qualification
Required
Deep understanding of statistical methodologies
Experience with sample size calculations
Knowledge of regulatory requirements within the medical device industry
Strong leadership skills
Ability to navigate complex analyses
Proficiency in statistical software
Strong communication/presentation skills
Experience in managing a biostatistics team
Ability to develop and implement statistical methodologies for sample size calculations and power analysis
Experience in generating randomization schedules
Ability to order, collate and interpret large volumes of diverse data
Experience in performing exploratory and confirmatory statistical analysis for studies
Ability to manage various datasets and determine summary statistics
Experience in conducting hypotheses testing and estimating statistical models
Ability to prepare statistical analysis plans
Experience in reviewing and providing input to study protocols and clinical study reports
Ability to collaborate with cross-functional teams including Regulatory Affairs, R&D, ADO, and Marketing
Knowledge of compliance with regulatory requirements and industry standards for statistical practices
Ability to present findings and statistical insights to stakeholders
Ability to stay updated with the latest advancements in biostatistics and medical device regulations
Ability to deliver special projects / ad-hoc reporting as needed
Benefits
Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
And additional employee wellness programs
Company
Insulet Corporation
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform.
Founded in 2000
1001-5000 employees
H1B Sponsorship
Insulet Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (58)
2024 (43)
2023 (19)
2022 (33)
2021 (41)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$629.5MKey Investors
DeerfieldOrbiMedAlta Partners
2025-03-18Post Ipo Debt· $450M
2009-03-16Post Ipo Debt· $60M
2007-05-15IPO
Leadership Team
Ashley McEvoy
President & Chief Executive Officer
Ana Maria Chadwick
Chief Financial Officer
Recent News
2025-12-20
2025-12-17
Company data provided by crunchbase