Biostatistician II

About the role

As a Biostatistician II at Boston Scientific, you will play an important role in supporting clinical trials through statistical analysis, programming and data interpretation. Working alongside cross-functional teams, you will apply statistical methodologies and provide innovative solutions that support scientific decision-making, clinical study design and the evaluation of medical device safety and effectiveness.

In this role, you will contribute to the development of statistical analysis plans, clinical study protocols and regulatory documentation while using SAS programming to generate data summaries, patient listings and reports. You will also collaborate with Clinical Sciences and other stakeholders to analyze clinical trial data, interpret results and communicate findings that support clinical research objectives.

Your responsibilities will include

• Generate statistical summary tables, patient data listings and clinical trial reports using SAS.
• Perform quality control reviews of SAS programs to ensure accuracy, consistency and reliability of statistical outputs.
• Troubleshoot complex SAS programming challenges and resolve study-related programming issues.
• Compile, organize and analyze clinical trial data and relevant supporting information.
• Collaborate with Clinical Sciences teams to develop scientifically sound clinical study designs and prepare statistical sections of clinical research protocols.
• Perform sample size calculations and statistical simulations to support clinical study planning.
• Provide input on clinical database requirements and develop SAS data set specifications.
• Develop statistical analysis plans and present methodologies and findings to cross-functional stakeholders.
• Develop and maintain SAS programs to generate periodic progress reports for assigned clinical trials.
• Support the interpretation of clinical trial data and contribute to the statistical methods and results sections of manuscripts and clinical study reports.

Required qualifications

• Minimum Bachelor's level degree will be considered with relevant experience.
• Minimum of 2 years' experience in SAS programming, preferably supporting medical device or pharmaceutical clinical trials.
• Previous internship experience with Boston Scientific.
• Basic knowledge of applicable clinical research regulatory guidelines, including FDA regulations, Code of Federal Regulations (CFR), ISO 14155, Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines.
• Proficiency in SAS programming and word processing applications.
• Familiarity with clinical trial design and statistical analysis methodologies.

Preferred qualifications

• Master's degree in biostatistics, statistics, public health or a related field.
• Experience using SQL and electronic clinical databases.
• Strong organizational and time management skills with the ability to manage multiple priorities.
• Strong interpersonal, written and verbal communication skills, including the ability to present statistical findings to cross-functional audiences.