Associate Sr. Fellow Biostatitiscian

Additional Location(s): US-MN-Maple Grove

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 Associate Senior Fellow Biostatistician is an integral member of the Biostatistics team of Boston Scientific’s Global Clinical Trials organization for Interventional Cardiology Therapies (ICTx). In this role, you will advise on biostatistical practices and methodologies in the medical device arena, focusing on clinical trial designs and data analyses to achieve both scientific and business goals. You will serve as a Subject Matter Expert on statistical questions across the ICTx clinical organization, applying current statistical methodologies, data knowledge, and regulatory/industry requirements to guide teams towards solutions.
 
You will lead the statistical aspects of clinical projects and activities, including protocol/SAP development, execution and oversight, data interpretation, regulatory submissions, and publication support. You will interact with Clinical and Medical Leadership, the clinical/medical writing team, KOLs, US and international regulatory agencies, and project teams. Additionally, you will oversee the work of statistical programmers (both internal and external CROs) and mentor junior biostatisticians and programmers.
 
Your responsibilities will include:

• Assume a leadership role and lead a team of biostatisticians to achieve the goals below
• Participate in discussions on early study design strategy and planning, research related data and feasibility, and propose potential statistical solutions to meet business goals.
• Develop the statistics section of the protocol, including study design methods, data simulations, sample size calculation, and statistical methods for data analyses. Develop the statistical analysis plan (SAP) and other relevant operational plans, such as randomization schema, safety triggers, and Data Monitoring Committee charter.
• Prepare statistical report templates, data specifications, and analysis datasets (ADS). Develop statistical programs using SAS® for statistical analysis and generating reports (TFLs) for internal and external projects, and maintain analysis plan and programming documentation as appropriate.
• Perform quality control and validation according to departmental processes and procedures. Ensure analysis is performed in accordance with applicable statistical methods and in compliance with regulatory and company standards.
• Represent Biostatistics on assigned clinical trials, providing statistical and operational expertise to support study objectives (e.g., timeline and budget).
• Lead and collaborate with internal or external team members (e.g., Statisticians/Programmers, Medical Writers, Medical Directors, and Physicians) in activities such as data integration and evidence generation, regulatory submission, study data publications, review and approval of relevant documents, and interpretation of statistical results.
• Lead continuous process improvement, including standardization and updates on new technical skills and regulatory and industry requirements and trends related to statistics and statistical programming.
• Determine, implement, and execute CRO activities for outsourced statistical and programming work per agreement, as well as validation of key study data. This includes managing CRO performance and building relationships with CRO leadership, managers, and programmers.

 
Required qualifications:

• Minimum of a master’s degree or higher in Biostatistics or equivalent.
• Minimum of 10 years of industry experience in clinical trials, with substantial knowledge related to medical devices as a Biostatistician, including study design methods, sample size calculations, statistical analysis, publications, and regulatory submissions (FDA/PMDA).
• In-depth understanding of statistical principles, clinical trial methodology, and regulatory requirements and guidance.
• Strong computational skills in R, SAS, or other statistical programming languages, with the ability to implement statistical methods and study designs through statistical programming, data simulations, and existing tools. Capable of providing practical, efficient, and supportive statistical solutions to difficult problems.
• In-depth knowled