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Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.
The Urology and Pelvic Health business unit provides proven, leading solutions to treat five common urology diseases, including kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), male incontinence and pelvic floor disorders. These conditions account for 50 percent of all urology surgical procedures. Additionally, we continue to invest in gynecologic surgical solutions for the treatment of abnormal uterine bleeding and uterine fibroids.
The Sr. Biostatistician is responsible for applying statistical and research methodological principles to the design, execution and analysis of clinical studies. Primary emphasis is on supporting clinical studies to assess the safety and efficacy of medical devices manufactured and distributed by BSC and analyzing clinical study data. This Senior level position will contribute to process improvement efforts in the statistics department as well as clinical division.
- Serves as a key partner and interacts regularly with clinical study teams in clinical trial design, evidence planning, and publications.
- Supports the design of clinical trials, including the recommendation of appropriate research design, sample size considerations, measurements of outcome variables, data collection forms design, expected data analysis/statistical procedures to be used, etc.
- Supports the development and documentation of the study protocol with primary responsibility for study design, which includes the statistical hypotheses, sample size, and analysis plan for meeting the study objectives.
- Supports the writing of statistical analysis plans for clinical trials.
- Assists with the development and review of case report forms to ensure data will be collected efficiently and effectively.
- Conducts statistical analysis and interpretation of clinical trial data and prepares reports to be submitted to the U.S. Food and Drug Administration and other regulatory bodies.
- Assists others in Regulatory and Clinical Affairs with data retrieval that will facilitate the monitoring of clinical trials.
- Participate in the preparation of abstracts, oral and poster presentations, and publications relating to the results of clinical studies. Respond to requests from clinical study investigators for statistical support with study design and data analysis.
- Interact with the clinical study investigators to determine optimal approaches for analyzing and interpreting data for publication and presentation.
- Participate in process improvement efforts to improve the efficiency of study conduct, data management, and data quality processes in clinical studies.
- Remain current on start-of-the-art statistical methods useful in clinical trial design and analysis; mentor junior level biostatisticians.
- Participate in the education of field support staff, clinical study investigators, study coordinators, and in the organization and presentation of materials for investigator site meetings; in addition, to participate in investigator meetings during the course of the study to discuss the clinical status of the study.
- Responsible for practicing Quality System Manual procedures and complying with its requirements, and carrying out responsibilities as outlined in safety, health and environmental policies.
- MS degree or higher in Biostatistics, Statistics, Biometrics or equivalent
- Bachelor’s may be considered if nearing completion of advanced degree and candidate has extensive related experience
- At least 3 years of experience in design and analysis of clinical studies, or at least 1 year with a Ph.D. degree
- Proven, strong applied statistical skills
- Advanced SAS programming skills
- Familiarity with data management in clinical trials
- Proficiency with FDA requirements and procedures for advisory panel meetings and PMA approvals
- Proficiency with PC database and statistical software such as SAS, etc.
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Requisition ID: 460396