Biostatistician-P2
About The Position
At Boston Scientific, the Biostatistician II supports clinical trials through statistical analysis, programming, and data interpretation. Working with cross-functional teams, the role applies statistical methodologies to support scientific decision-making, clinical study design, and evaluation of medical device safety and effectiveness. The position contributes to statistical analysis plans, clinical study protocols, and regulatory documentation. It uses SAS programming to produce data summaries, patient listings, and reports, and collaborates with Clinical Sciences and other stakeholders to analyze trial data, interpret results, and communicate findings. The role is onsite at a local office at least three days per week. Relocation and employment visa sponsorship are not available for this position.
Requirements
- A minimum bachelor's-level degree will be considered with relevant experience.
- At least 2 years of 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.
Nice To Haves
- 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.
Responsibilities
- Generate statistical summary tables, patient data listings, and clinical trial reports using SAS.
- Perform quality control reviews of SAS programs to ensure the 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 interpretation of clinical trial data and contribute to statistical methods and results sections of manuscripts and clinical study reports.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
