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Statistician II

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Company :
CareFusion

Location :
Franklin Lakes, New Jersey

Expiry Date :
Sun, 13 Dec 2020 23:59:59 GMT

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Description :
Job Description Summary Job Description The Statistician II will provide statistical support for clinical trials and for R & D, manufacturing, quality, marketing, and finance as needed. The projects may be of moderate scope and complexity. Duties: – Consult with clinical and project teams, plan and analyze studies/experiments/surveys; use statistical knowledge to support and guide business decisions and to help facilitate strategic decision making for management and project teams. – Program, document, and validate software code to execute data handling tasks, perform data analysis, and produce data visualization results. Present analyses and interpretations to internal and external customers. – Establish and maintain sound working relationships with other functional groups. Provide technical leadership and guide other statisticians. – Assist in delivering training for non-statistical professionals. – Consult with clinical and project teams, plan and analyze clinical or non-clinical studies; use statistical knowledge to support and guide business decisions and to help facilitate strategic decision making for management and project teams. – Program, document, and validate software code to execute data handling tasks, perform data analysis, develop statistical approaches to handle non-standard statistical problems, and produce data visualization results. – Provide statistics deliverables for projects to meet schedules and goals for multiple businesses and platforms. – Develop/revise work plans independently except for unusual situations, which might require consultation. – Review and/or prepare formal written reports/documents for distribution within and outside the department. – Identify and work to implement process improvement initiatives within the Statistics function or across related functions. – Keep abreast of new statistical developments and regulatory guidance; survey related fields for techniques that could be adapted to BDs needs. – Represent BD with external organizations, regulatory authorities, and key opinion leaders. – May make presentations or contribute to publications for industry-related conference and journals. – Assist in delivering training to non-statistical professionals. – Establish and maintain sound working relationships with other functional groups. Skills and Requirements: – Demonstrated competence in the application of statistical techniques used in product development, clinical trials, manufacturing operations, quality, regulatory, and continuous improvement is required. In addition to those required, demonstrated competence in the application of statistical techniques used in financial forecast modeling, and business analytics for marketing and sales data is preferred. – Ability to program, document, and validate statistical software code in R is required. – Knowledge and experience working in a reproducible research environment is preferred. – Working knowledge of applicable regulations and the ability to apply without supervision is preferred. – Ability to identify process improvement opportunities within the Statistics function or across related functions, and work or collaborate to implement them is required. – Ability to credibly represent a BD Business or function to external stakeholders, such as business partners, regulatory authorities, and key opinion leaders is required. – Ability to exercise strong professional judgment is required. – Demonstrated strong leadership skills and the ability to influence without direct authority are required within the function. – Ability to assist in delivering training to non-statistical professionals is required. – Demonstrated capability of working on multiple projects at one time is required. – Strong oral and written communication skills are required. – Strong interpersonal skills are required. Specifically, cross functional collaboration, listening and negotiation skills are critical. Requirements Required: – A minimum of a Masters degree required in Statistics, Biostatistics, or related field (math, physics, computer programming). – 3+ years of experience in a regulated industry with device and/or healthcare industry is required with Masters degree (5+ preferred) or healthcare industry. Preferred: – PhD. preferred with 1 year of experience. – Coursework in physical, biological, or social sciences is a preferred. – Experience providing statistical consulting for non-statisticians is preferred. – Experience working with FDA and/or other regulatory bodies outside of submission work is preferred (i.e. guidance document generation, meetings/clinics). 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