Biostatistician Manager,Clinical Affairs; Hybrid Job San Diego area,California USA,IT/Tech

Position: Biostatistician Manager, Clinical Affairs (Hybrid)

Job Title: Biostatistician Manager, Clinical Affairs

Department: Clinical

FLSA Status: Exempt

Position Overview:

The newly created Biostatistician Manager role will report directly to the Senior Manager, Global Clinical Affairs Data. This position will play a critical role in leading the team and providing expert statistical support for internally sponsored, real-world evidence (RWE), and external clinical studies. The position requires a deep understanding of statistical methodologies, sample size calculations, and regulatory requirements within the medical device industry.

The role also demands strong leadership skills, the ability to navigate complex analyses, and proficiency in statistical software.

The Biostatistician Manager will collaborate closely with cross-functional teams to ensure the successful development and approval of medical devices. Additionally, this role will demonstrate strong communication and presentation skills and will 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 developing 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 and ad-hoc reporting as needed.

Note:

This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 3x/week; may work remotely on other days). #LI-Hybrid

Additional Information:

The US base salary range for this full-time position is $122,700 - $184,050. Salary ranges are determined by role, level, and location. The displayed range reflects the minimum and maximum target for new hire salaries in the primary US work location. Actual pay is influenced by work location, skills, experience, and education. More details can be provided during the hiring process.

Compensation listed reflects base salary only, excluding bonuses, equity, or benefits.

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is dedicated to simplifying life for people with diabetes through its Omnipod product platform, including the Omnipod 5 Automated Insulin Delivery System. For more information, visit and

We seek highly motivated, performance-driven individuals to join our expanding team, guided by shared values and a commitment to exceeding customer expectations. Our success depends on our people!

At Insulet Corporation, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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Biostatistician Manager, Clinical Affairs; Hybrid