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Regulatory Biostatistician (REMOTE)

Company: Becton Dickinson
Location: San Diego
Posted on: June 25, 2022

Job Description:

Responsibilities Job Description Summary Job Description Be part of something bigger BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. Reporting to Sr. Director, Regulatory Affairs New Product Development (NPD), the Regulatory Affairs (RA) Biostatistician is responsible for providing support and content for Regulatory submissions, including but not limited to statistical review and assessment of sample size and related data. Responsibilities include the creation of data related regulatory strategies, assessment of sample sizes and significance as well as other data associated with Regulatory submission requirements, supporting international registrations, interpreting and providing regulatory requirements, ensuring department processes and procedures related to associated regulatory responsibilities are compliant, current and efficient, and mentoring regulatory associates. Duties and Responsibilities: Participate as an active, engaged member of a global team on core projects by partnering with cross functional teams to build and implement regulatory strategies in support of new or modified devices for all MMS platforms. Serve as a biostatistical consultant to MMS global Regulatory Affairs staff, with understanding of varying regional perspectives; provide statistical guidance and support to facilitate decision making. Review test protocols for proposed studies with respect to statistical methodology and appropriate sample sizes; review test reports and associated data to confirm adherence to valid statistical methods and associated required sample sizes. Support the review and assessment of protocol deviations to the extent that they affect statistical analyses. Work with cross-functional colleagues to ensure results are presented accurately and clearly Assist with preparation of protocol and report summary documentation for domestic and international Regulatory submissions. Engage with Quality teams on the execution of corrective action plans. Monitor changes in US and EU regulatory requirements related to acceptable statistical methods and sample size determinations; stay on top of new developments in statistics, device development, and regulatory guidance. Ensure that Regulatory department processes and procedures related to responsibilities are compliant, current and efficient. Review, approve, and maintain documentation within MMS electronic systems Ensure that related Regulatory policies, SOPs and Work Instructions are properly developed, approved and maintained. Provide Regulatory support for internal and third-party regulatory inspections, such as ISO and FDA audits. Analyze regulatory issues, providing input into corresponding risk assessments and guidance on developmental paths forward. Educate and advise non-statisticians (e.g., project management, team members, etc.) on statistical methodologies and approaches Perform other duties and assignments as required. Minimum Qualifications: Able to be a self-starter, highly motivated and enthusiastic Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices, including analytical problem solving. Able to juggle multiple tasks and to prioritize and schedule work to meet business needs. Thorough understanding of descriptive statistics, hypothesis testing, non-parametric, and multivariate statistical tests Outstanding ability to communicate technical information to both technical and non-technical audiences Ability to be effective in complex projects with ambiguity and/or rapid change Excellent written and verbal communication skills including ability to communicate across culture; work with others in team environment; effective interactions with personnel (scientific and legal); and negotiate with Regulators. Digital literacy (SAP, PC, Microsoft Word/Excel/PowerPoint) Orientation for detail work product, with emphasis on accuracy and completeness. Familiar with Design control documents; History Files, Device History Records, QC testing, Stability reports, etc. Available to travel 25% as needed Education and Experience: BS or MS degree in statistics, biostatistics, or a related subject area Minimum of 4 years directly applicable work experience in the medical device industry Minimum 4 years of experience performing statistical analyses in a regulated environment, preferably medically related including FDA, GCP or other relevant area Minimum of 4 years' experience working with US 510(k)/PMA and CE Tech Files, ideally including software-based medical devices and related products Expertise in standard statistical techniques (experimental design, statistical modeling, sample size determination, statistical simulation) Knowledge in appropriate statistical software such as JMP, Minitab, & ReliaSoft in a regulated industry and/or experience with regulatory audits and certification management For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why join us? A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components - is designed to support the varying needs of our diverse and global associates. To learn more about BD visit Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. PDN LI-PRO Primary Work LocationUSA CA - San Diego TC Bldg C&D Additional Locations Work Shift Apply Save Job PDN-963ee1bf-40ec-4e2d-8601-9df80f9c13aa

Keywords: Becton Dickinson, San Diego , Regulatory Biostatistician (REMOTE), Other , San Diego, California

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