דרושים Statistical Programmer Ii ב-Boston Scientific ב-United States, Minnetonka

About the role:

As a Statistical Programmer II, you will support clinical research by developing and validating SAS programs to generate analysis datasets, tables, listings, and figures. You will collaborate with cross-functional teams to ensure clinical data analysis meets regulatory and internal standards. This role supports the Boston Scientific Urology team and reporting to a Principal Statistical Programmer.

Work mode:

This position follows a hybrid work model, requiring on-site presence at our Minnetonka, Minnesota office at least three days per week.

Your responsibilities will include:

• Develop and validate SAS programs for clinical data analysis.
• Extract and convert clinical data from various databases into SAS format.
• Generate statistical summary tables, listings, and figures.
• Apply appropriate statistical procedures and methods.
• Conduct quality control checks on SAS programs and outputs to ensure accuracy and compliance.
• Contribute to programming standards, templates, and macro development.

Required qualifications:

• Bachelor’s degree in Statistics or related field or Master’s degree or equivalent experience
• Minimum 2 years of SAS programming experience in clinical research.
• Proficiency in SAS Base, STAT, GRAPH, and ACCESS.
• Strong communication and collaboration skills.

Preferred qualifications:

• Master’s degree in Statistics or related field.
• Knowledge of FDA CFR Part 11 compliance.
• Experience with Medidata RAVE and Snowflake.
• Prior experience in Urology clinical studies.
• Excellent communication and collaboration skills.

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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.

Spencer Gregory Hale

Your responsibilities will include:

• Drives improvement and corrective action in the quality of components sourced from outside suppliers.

• Provides technical support in the selection of suppliers and develops acceptance criteria for materials.

• Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures.

• Assess suppliers for technical, quality and manufacturing capabilities.

• Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a broad knowledge of a variety of alternatives and their impact on the business unit.

• Plans and organizes non-routine tasks with approval. Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedules.

• Works under general direction regarding the direction and progress of projects and special assignments. Independently determines and develops approaches to solutions. Interprets, executes, and recommends modifications to company policies. Assists in establishing departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting objectives.

• Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. Interacts with suppliers. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represent a specialized field in larger project teams. Influences middle management on business solutions.

• Contributes to the completion of specific programs and projects. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.

• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Quality Policy. Establishes and promotes a work environment that supports the Quality Policy and Quality System.

What we're looking for in you:
Minimum requirements:

• BS degree in Mechanical Engineering, Materials Engineering, Chemical Engineering, Electrical Engineering, or similar technical degree with 2+ years related experience.

• Ability to travel up to 10% of the time.

Preferred Qualifications:

• Mechanical or Electrical Engineering background preferred.

• Experience in working with mechanical, electrical, or chemical component suppliers

• Experience working in the Medical Device industry

• Experience with manufacturing support or process development

• Experience with auditing quality systems or ISO13485, 9001, TS16949 standards

• Experience in lean and six sigma methodologies

• Experience with project management

Maximum Salary: $ 132000

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Your responsibilities will include:

• Generates analysis datasets, statistical summary tables, listings, figures, and reports primarily using SAS.
• Extracts clinical data from a variety of databases and converts to SAS format.
• Performs quality control checks of SAS programs.
• Develops programming standards, templates, and macros in collaboration with Statistical Programming group.
• Compiles clinical data, statistical summary tables, listings, and figures, and presents these results to the
• Biostatistician and internal clinical teams for review.
• Assists with template development and contributes to statistical analysis plans under the direction of the Biostatistician.
• Researches and applies statistical procedures and methods as needed.

Required qualifications:

• Bachelor’s Degree in statistics or related field or equivalent experience required
• Minimum five years of statistical programming experience using SAS to analyze clinical study data.

Preferred qualifications:

• Master’s Degree in statistics or related field preferred
• Experience with Snowflake and Medidata RAVE preferred
• Prior experience in Urology preferred
• Proven knowledge of FDA CFR Part 11 compliance and clinical study processes.
• Excellent interpersonal communication and project coordination skills with demonstrated ability to effectively interface with internal and external customers.
  

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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.