Job Description Summary # Job Description Job Description Manage the Statistics needs for one or multiple businesses from within Global Clinical Development. Be the point-of-contact on statistical deliverables for projects and responsible for coordinating the statistical resources who will provide support for clinical trials as well as support for some non-clinical statistical needs. Supervise work on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business, medical, and regulatory trends. Independently manage local and remote resources with limited supervision. Coach, mentor, and develop direct reports and other associates within GCD. The senior manager is recognized internally as a subject matter expert in the area of statistics, in particular for in vitro diagnostics and/or therapeutic devices. This is a working senior manager position. In this role, the incumbent will directly contribute to company success by increasing the strength of study designs and interpretability of results, and by implementing continuous improvement practices in all areas of research that involve statistical analysis of data. In addition, the incumbent may consult with clinical and project teams, plan and analyze clinical studies; use results to address business issues; program to create new applications and extend current ones; present analyses and interpretations to internal and external customers; establish and maintain sound working relationships with other functional groups. ## Primary Responsibilities + Point-of-contact for the coordination of statistical activities and resources for one or multiple businesses + Direct supervision, management, and leadership of a small statistics group to provide sound statistical judgement and expertise, which may impact medical, regulatory, clinical, and new product development decisions regarding product safety and performance, and to provide statistics deliverables for projects to meet schedules and goals. + Assure adherence to budgets, schedules, work plans, and performance requirements. + Act as advisor to subordinates to meet schedules and/or resolve technical problems. + Champion standardization and development of best practices to improve quality, efficiency and effectiveness of the group + Review and/or prepare formal written reports/documents for distribution within and outside the department. + Participate in vendor selection and oversee statistical activities performed by vendors. + Evaluate and monitor both internal and external trends in statistics and regulatory guidance to identify relevancies to BD with respect to approaches to clinical operations, regulatory, and new product development for increasing efficiency and effective. + Provide statistical support to the planning, authoring, and review of manuscripts, publications and other scientific data disclosures + Forecast, coordinate and monitor statistical resource allocations for specific business. Support other businesses based on availability. + Recruit, interview, and contribute to hiring decision for permanent, temporary, and contract staff. + Responsible for annual performance assessments and development plans for associates. Coach and mentor others and assist in their development through development planning, active mentoring programs, or creation of opportunities for their development. ## Reporting The position reports to the Associate Director, Statistics, Global Clinical Development. ## Minimum Qualifications + 5+ years of experience in a regulated industry with device and/or healthcare industry is required. + 1+ years of experience as a manager/supervisor is required. + Proven track record working with regulatory bodies – US (FDA) is required. + A minimum of a Master’s degree required in Statistics, Bio-statistics, or related field. + Demonstrated competence in the application of statistical techniques used in clinical trials, real-world evidence generation, product development, manufacturing operations and quality is required. + Knowledge of applicable regulations is required. Ability to mentor/teach/interpret regulations/standards and to support internal teams in generating new procedures or revise existing procedures and/or practices and systems as needed for process improvement and/or compliance is required. + Ability to work on issues of diverse scope and which may involve multiple geographies, where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends, medical practice and regulatory issues. + Knowledge of other related disciplines, such as: Clinical Programming, Clinical Data Management, and Clinical Operations is required. + Ability to credibly represent a BD Business or function to external stakeholders, such as business partners, regulatory authorities, and key customers is required. + High level of organizational savvy is required. Ability to exercise strong professional judgment is required. Ability to serve as a role model within the organization is required. + Strong interpersonal skills are required. Specifically, cross functional collaboration, listening and negotiation skills are critical. Preferred + 8+ years of experience in a regulated industry with device and/or healthcare industry is preferred. + PhD in Statistics, Bio-statistics, or related field + Experience working with FDA and/or other regulatory bodies outside of submission work preferred (i.e. guidance document generation, meetings/clinics.) is preferred. + Ability to program, document, and validate statistical software code in at least one statistical programming language, such as R or SAS, is required. Knowledge of reproducible research is preferred. 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. #LI-PRO # Primary Work LocationUSA NJ - Franklin Lakes # Additional Locations # Work Shift 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.