Biostatistics Manager I

Additional Location(s): N/A; US-MN-Arden Hills

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role:
The Manager I, Biostatistics position will manage a team of biostatisticians supporting clinical trials, publications, and real-world evidence initiatives through all phases. Important aspects of this role include developing team members, providing strategic input for clinical trial and data and evidence needs, and leading process and efficiency initiatives. Our team of innovative Biostatisticians work collaboratively on a wide range of projects. As the manager of this team, you will resource and prioritize projects, provide support as needed, and develop and coach team members. This role is hybrid and requires reporting onsite in Arden Hills, 2-3 days a week.

Your responsibilities include:

• Take an active role in assisting the clinical department to define their strategy for clinical studies, PMCF activities, and other clinical data and evidence needs
• Oversee biostatistical issues related to appropriate study design and hypothesis development
• Oversee the quality of the statistical design and analysis and ensure that worldwide processes are implemented in compliance with applicable regulations
• Provide guidance on real world data initiatives
• Provide guidance or interface directly with regulatory authorities (e.g. FDA) on statistical and data issues pertaining to study design, data collection, hypothesis testing, and study results
• Leverage knowledge of biostatistical practices and methodologies in the medical device arena to recruit, train, develop and mentor team members
• Resource team members to support clinical trials, publications, post market clinical follow-up activities, real world evidence initiatives and projects, and statistical consulting and analysis requests
• Monitor regulatory initiatives (US and international) and innovative practices that impact biostatistics and implement appropriate changes to the groups’ practices to ensure regulatory compliance
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives

Required qualifications:

• Postgraduate degree or appropriate equivalent experience in biostatistics or statistics required.
• 8+ years of work experience in clinical research in medical device or pharmaceutical industry.
• At least 1 year of managerial experience
• In-depth familiarity with the FDA, ISO, EU MDR and the medical device industry requirements associated with clinical trials and statistical methods
• Skilled in organization and ability to prioritize multiple projects
• Excellent interpersonal, written and oral communication skills
• Ability to work onsite in Arden Hills, MN 2-3 days a week

Preferred qualifications

• Cardiac medical device study experience
• 8+ years medical device clinical research experience

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Requisition ID: 561922

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.