Insulet Corporation
Biostatistician Manager, Clinical Affairs (Hybrid)
Insulet Corporation, Oklahoma City, Oklahoma, United States
Job Title: Biostatistician Manager, Clinical Affairs
Department: Clinical
FLSA Status:
Exempt
Position Overview: The newly created Biostatistician Manager role reports directly to the Senior Manager, Global Clinical Affairs Data. This position leads the team and provides expert statistical support for internally sponsored, real-world evidence (RWE), and external clinical studies. It requires a deep understanding of statistical methodologies, sample size calculations, and regulatory requirements within the medical device industry. Strong leadership skills, the ability to navigate complex analyses, and proficiency in statistical software are essential.
The Biostatistician Manager collaborates closely with cross-functional teams to ensure the successful development and approval of medical devices. The role also demands strong communication and presentation skills to support senior leaders in data analytics.
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.
Generate randomization schedules.
Order, collate, and interpret large volumes of diverse data; perform exploratory and confirmatory statistical analyses for studies.
Manage datasets, determine summary statistics, conduct hypothesis testing, estimate statistical models, and prepare reports.
Design and conduct complex statistical analyses for clinical studies, RWE, and other data needs.
Prepare statistical analysis plans, including mock-up displays for tables, listings, and figures.
Review and contribute to study protocols and clinical study reports.
Collaborate with Regulatory Affairs, R&D, ADO, and Marketing to ensure robust statistical support.
Ensure compliance with regulatory requirements and industry standards.
Present findings and insights to stakeholders, including senior management and regulatory bodies, effectively communicating statistical concepts.
Stay updated on advancements in biostatistics and medical device regulations.
Deliver special projects and ad-hoc reports as needed.
Note:
This position is eligible for hybrid working arrangements (requires on-site work at least 3x/week; remote work possible on other days).
Additional Information: The US base salary range is $122,700 - $184,050, determined by role, level, and location. Compensation details reflect base salary only, excluding bonus, equity, or benefits.
About Insulet Corporation: Insulet is an innovative medical device company dedicated to simplifying life for people with diabetes. Our flagship product, the Omnipod Insulin Management System, offers a tubeless, disposable insulin delivery option. We also develop the Omnipod 5 Automated Insulin Delivery System and tailor technology platforms for other therapeutic areas.
Equal Opportunity Employment: We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
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Exempt
Position Overview: The newly created Biostatistician Manager role reports directly to the Senior Manager, Global Clinical Affairs Data. This position leads the team and provides expert statistical support for internally sponsored, real-world evidence (RWE), and external clinical studies. It requires a deep understanding of statistical methodologies, sample size calculations, and regulatory requirements within the medical device industry. Strong leadership skills, the ability to navigate complex analyses, and proficiency in statistical software are essential.
The Biostatistician Manager collaborates closely with cross-functional teams to ensure the successful development and approval of medical devices. The role also demands strong communication and presentation skills to support senior leaders in data analytics.
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.
Generate randomization schedules.
Order, collate, and interpret large volumes of diverse data; perform exploratory and confirmatory statistical analyses for studies.
Manage datasets, determine summary statistics, conduct hypothesis testing, estimate statistical models, and prepare reports.
Design and conduct complex statistical analyses for clinical studies, RWE, and other data needs.
Prepare statistical analysis plans, including mock-up displays for tables, listings, and figures.
Review and contribute to study protocols and clinical study reports.
Collaborate with Regulatory Affairs, R&D, ADO, and Marketing to ensure robust statistical support.
Ensure compliance with regulatory requirements and industry standards.
Present findings and insights to stakeholders, including senior management and regulatory bodies, effectively communicating statistical concepts.
Stay updated on advancements in biostatistics and medical device regulations.
Deliver special projects and ad-hoc reports as needed.
Note:
This position is eligible for hybrid working arrangements (requires on-site work at least 3x/week; remote work possible on other days).
Additional Information: The US base salary range is $122,700 - $184,050, determined by role, level, and location. Compensation details reflect base salary only, excluding bonus, equity, or benefits.
About Insulet Corporation: Insulet is an innovative medical device company dedicated to simplifying life for people with diabetes. Our flagship product, the Omnipod Insulin Management System, offers a tubeless, disposable insulin delivery option. We also develop the Omnipod 5 Automated Insulin Delivery System and tailor technology platforms for other therapeutic areas.
Equal Opportunity Employment: We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
#J-18808-Ljbffr