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Senior Biostatistician
Ref No.: 18-17501
Location: Irvine, California
The Biostatistician 4 will be responsible for leading statistical and analytical services in support of clinical trials, regulatory submissions, marketing efforts, and quality initiatives, as well as providing guidance on standards, processes, and technical topics within the statistics team.  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.
  • Provide guidance on standards, processes, and technical direction within the biostatistics team.
  • Interact with Biostatistics, Data Management, Regulatory, and Clinical staff to define and clarify project requirements.
  • Design and execute statistical plans independently for all phases of clinical studies, assuming a leadership role in creating strategy for study design and analyses.
  • Review clinical study protocols and Case Report Forms (CRFs) for proposed studies with respect to statistical methodology.
  • Supervise generation of randomization schemes; supervise unblinding of treatment assignments and appropriate handling of unblinded information.
  • Lead 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 (e.g., statistical power analysis).
  • Assist in the preparation and documentation of results to support trial reports and publications.
  • Act as a statistical consultant to the business units and external customers on statistical issues.
  • Interface with surgeons to assist in drafting peer-reviewed journal articles.
  • Participate in vendor evaluation, selection, contracting, and oversight for statistical and programming deliverables.
  • Provide statistical reports for data quality/performance metrics.
  • Assist Clinical Research with literature reviews and other activities.
  • May assist in presenting information at professional meetings.
  • May oversee the statistical deliverables produced by lower-level biostatisticians or external consultants.
  • May oversee production of presentation materials for presentations at professional meetings.
  • Stay current with statistical methodology in clinical trial design and analysis.
Functional and Technical Competencies:
  • Demonstrated technical experience in preparing statistical deliverables on time.
  • Thorough understanding of .
  • Ability to assist in selecting and defining independent and dependent variables in the field of application.
  • Ability to contribute to strategic planning.
  • Experience with .
  • Knowledge of .
  • A thorough understanding of is required.
  • Excellent verbal and written communication skills.
  • Knowledge of Microsoft packages; PowerPoint, Excel, Word.
  • Proficient in SAS. Familiarity with other statistical packages for handling smaller datasets and power analyses.
Leadership Competencies:
  • Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
  • Diligently participate in client's compliance program-related activities as denoted by client leads and the client Chief Compliance Officer.
  • Strong leadership required in alignment with client's Leadership Imperatives: Connect, Shape, Lead, Deliver  as noted below.
    • Connect  - Manage multiple objectives from diverse stakeholders
    • Shape – Develop knowledge of therapeutic areas within the Franchises and translate key insights into evidence claims or product differentiators
    • Lead – Make decisions regarding the selection of statistical tests to be performed and how to present data.
    • Deliver – Ensure statistical deliverables are produced on time, within budget and in compliance with regulations and SOPs
  • A Master's degree in Statistics.
  • At least 6 years of experience (or Ph.D. with 4 years) performing statistical analyses in a regulated environment, preferably medically related including FDA, GCP or other relevant area.
  • At least 4 years of experience as a clinical trial biostatistician, preferably in medical/surgical device trials.
  • Familiar and experienced with such as
  • study design
  • protocol development
  • study endpoint determination
  • CRF development
  • statistical analysis plan development
  • sample size calculations
  • table shell development (preparation for analysis)
  • statistical analysis
  • supporting written summaries and reports of study outcomes

Location: Irvine, CA (100% onsite)- Willing to accept relocation candidates