Manager, Biostatistics - (job Number: 0716677)
Johnson & Johnson (Philadelphia, Pennsylvania)

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Description

Centocor Researchand Development, a member of Johnson & Johnson's Family of Companies, is recruiting for a Mgr, Biostatistics, located in Chesterbrook, PA.Centocor Research and Development, develops innovative biomedicines. The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders.POSITION SUMMARY: Statistician working and training on trial design and reporting activities with minimal review. Prepares statistical aspects of development plans for new drug indications with review. Statistics representative for cross-functional teams and for review within Biostatistics and Clinical Research.ESSENTIAL FUNCTIONS: 1. Leads statistical input for at least one disease indication, including review within Biostatistics and Clinical Research.2. Leads clinical study design.3. Leads analysis planning for clinical studies.4. Leads statistical input to clinical study reports.5. Provides statistical support to other disciplines associated with clinical statistics.6. Serves as a primary contact with outside investigators in the preparation of scientific presentations and manuscripts.7. Takes a leadership role in process improvement, training, standards development or an area of technical expertise.OTHER RESPONSIBILITIES / DETAILED DUTIES:1. Responsible for statistical aspects of clinical development for at least one new drug indication with review. May be a Clinical Team member.2. Provides statistical input and leadership to clinical areas of project development. Responsible for the appropriateness of statistical methods and accuracy of results for all aspects of the project.3. Responsible for the design of protocols and preparation of statistics section of protocols.4. Responsible for analytical plan preparation, detailed analysis planning and other statistical aspects of trial setup activities.5. Independently analyzes and interprets data; responsible for writing statistical methods section for clinical study reports.6. Ensures compliance with department SOP's and regulatory guidance.This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.

Education: Masters degree in Statistics or related field and at least 6 years experience, or PhD in Statistics or related field and at least 4 years experience.Related Experience: Basic knowledge of SAS programming and at least some other significant statistical software (e.g., S-Plus, PASS 2000). Basic knowledge of regulatory guidance documents such as ICH guidances. Demonstrated written and oral communication skills. Ability to work independently.If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today!

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