Regulatory Biostatistician (REMOTE)
Company: Becton Dickinson
Location: San Diego
Posted on: June 25, 2022
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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
https://jobs.bd.com/ 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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