Senior Biostatistician
Location:
West Chester , Pennsylvania
Posted:
April 02, 2017
Reference:
2402170214/2-en-us

The Johnson and Johnson Medical Device (MD) Sector Clinical Research and Development Center of Excellence (CR&D COE) is recruiting for a Senior Biostatistician. The preferred location is Raynham MA, however we are also open to our West Chester, PA, or Warsaw, IN locations.  


The MD CR&D COE is being created to support all clinical activities across all business units within the Johnson & Johnson Medical Device companies.  The COE organization is based on three functional teams: Franchise, Operations and Biostatistics & Data Management.  All three teams share accountability for the successful development and delivery of clinical evidence globally to internal and external stakeholders that drives innovation in surgical solutions and that optimizes the product lifecycle.  Each team within CR&D COE will have primary responsibility for defined areas of clinical program development, execution and dissemination.


The Senior Biostatistician will be responsible for designing statistical analysis plans for clinical studies; performing statistical analyses independently; creating reports intended for internal distribution and for regulatory submission; creating internal presentations and white papers; and interfacing with surgeons to assist in drafting peer-reviewed journal articles.  His/her work will follow guidance from Biostatistics management, and will adhere to applicable regulations for pre- and post- market clinical trials. S/he ensures statistical analyses are conducted with the highest level of scientific integrity, while meeting timelines and budgets. Reporting to the Biostatistics Manager.

 

Responsibilities:

 
    • Interact with Biostatistics, Data Management, Regulatory, and Clinical staff to define and clarify project requirements.
    • Design and execute statistical plans for all phases of clinical studies of moderate complexity under limited supervision.
    • Review clinical study protocols and Case Report Forms (CRFs) for proposed studies with respect to statistical methodology.
    • Generate randomization schemes; unblind treatment assignments and handle unblinded information appropriately.
    • Support the review and assessment of protocol deviations to the extent that they affect statistical analyses.
    • Produce statistical reports that may be incorporated into internal clinical reports or regulatory submissions.
    • Contribute to peer-reviewed articles independently, in coordination with the lead author/physician.
    • Review articles on topics relevant to specified products and provide reports concerning issues relating to statistical methodology.
    • Assist with preparation of documentation for IRB/Ethics Committee submissions
    • Assist in the preparation and documentation of results to support trial reports and publications.
    • Resolve complex statistical issues from business units and external customers.
    • Provide statistical reports for data quality/performance metrics.
    • Assist Clinical Research with literature reviews and other activities.
    • May assist in preparing information and materials for presentation at professional meetings.
    • Stay current with statistical methodology in clinical trial design and analysis.


Qualifications
  • A Master’s degree in Statistics, Biostatistics, or Applied Statistics with at least 4 years of experience OR a Ph.D. with at least 2 years of experience performing statistical analyses in a regulated environment, preferably medically related is required.
  • Knowledge of US law, regulations, and FDA guidance covering good clinical practice (GCP) is required.
  • Demonstrated technical experience in preparing statistical deliverables on time is required.
  • Thorough understanding of descriptive statistics, power/sample size analysis, hypothesis testing, non-parametric, and multivariate statistical tests is required.
  • Ability to assist in selecting and applying statistical methods in the field of application is required.
  • Experience with survival analysis, longitudinal data analysis, and other current statistical methodologies is required.
  • Excellent verbal and written communication skills are required.
  • Proficiency in SAS and Microsoft software (Word, Excel, PowerPoint) is required.
  • Ability and willingness to travel up to 10% is required.
  • Familiarity with other statistical packages and power analysis software is preferred.
  • Knowledge of Bayesian statistics, meta-analyses, or simulation techniques is preferred.
  • Understanding of the processes involved in strategic planning is preferred.


Primary Location
United States-Massachusetts-Raynham
Other Locations
North America-United States-Pennsylvania-West Chester, North America-United States-Indiana-Warsaw
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Biostatistics
Requisition ID
2402170214

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