Boston Scientific Fellow Biostatistician - Interventional Cardiology Therapies 

United States, Massachusetts, Marlborough 

877620567

US-MN-Maple Grove

About the role:
The 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:

• 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 knowledge of the SAS® programming language and common statistical methods/tests. Proficient in SAS® Macro programming, ODS/RTF, and ODS/GRAPH. Extensive working experience and statistical knowledge using various SAS/Stats Procedures (e.g., Logistic, GLM, PHReg, and Lifetest).

Preferred qualifications:

• Extensive knowledge and experience in clinical trials within the Interventional Cardiology area, including Bayesian design and analysis, adaptive design, RWD/RWE, and other novel statistical methods.
• Proficiency in various statistical programming packages or software, such as R, Python, WinBugs, East, and PASS, with experience presenting statistical methods or programming techniques at major conferences.
• Familiarity with Common Data Model (CDM) or related data models and database structures, as well as experience in data mining or data science related to clinical studies.
• Strong communication skills in both technical and non-technical settings, both written and verbal, with a proven track record of working in cross-functional teams in global and remote settings.
• Demonstrated ability to manage multiple projects, conflicting priorities, and changing priorities, with solid experience overseeing and managing statistical programmer work, whether in an internal group or with a CRO. Attention to detail, excellent problem-solving skills, and a self-motivated approach to proactively identifying and addressing issues.

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.