Boston Scientific Senior Biostatistician 

United States, Minnesota, Minnetonka 

331606091

US-MN-Minnetonka; US-MN-Arden Hills; US-MN-Mankato/Rochester; US-MN-Maple Grove; US-MN-Minneapolis; US-MN-Northern/Duluth; US-MN-Plymouth

**This role requires hybrid (three times a week) at our Minnetonka BSC location.**

About this role:

The Senior 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 Urology and Pelvic Health and analyzing clinical study data. This Senior level position will contribute to process improvement efforts in the statistics department as well as clinical division.

Your responsibilities will include:

⦁ 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.

⦁ Minimum Master's degree required in Biostatistics or related field
⦁ Minimum 3 years of experience in design and analysis of clinical studies, or minimum 1 year experience with a Ph.D. degree
⦁ Proven, strong applied statistical skills
⦁ Advanced SAS programming skills

Preferred qualifications:
⦁ Proficiency with FDA requirements and procedures for advisory panel meetings and PMA approvals
⦁ Proficiency with PC database and statistical software such as SAS, etc.
⦁ R and/or Python experience is a plus

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.