United States onlyJob Title:Biostatistician Manager, Clinical Affairs
Department:Clinical
FLSA Status: Exempt
Position Overview:
The newly created Biostatistician Manger 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 position requires 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. In addition, this role will demonstratestrong communication/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.
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 bodiesand effectively communicate statistical concepts.
Stay updated with the latest advancements in biostatistics and medical device regulations.
Deliver special projects / ad-hoc reporting as needed.
Develop and maintain internal SOPs to establish formal procedures ensuring the quality of statistical aspects of studies
Education and Experience:
Master's or Ph.D. in Biostatistics, or Statistics.
Minimum of 6+ years of experience in biostatistics within the medical device industry.
Proven experience in navigating complex statistical analyses and sample size calculations.
Strong knowledge of clinical trial design and regulatory requirements.
Strong knowledge of statistical methodologies, experimental design, and analytical and problem-solving abilities.
Effective communication skills, both written and verbal.
Ability to work collaboratively in a fast-paced, multidisciplinary environment.
Skills/Competencies:
Proficiency in statistical software, including SAS, R, SPSS, and other relevant tools.
Excellent leadership and team management skills with the ability to multi-task.
Diabetes experience a plus.
NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired).
Additional Information:
The US base salary range for this full-time position is $122,700.00 - $184,050.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.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. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.
We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
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 status as a protected veteran.
Mexico only
