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Title:Director Biostatistics
Salary:200-250K
Experience:7+
Location:CA - San Francisco Area

Description:
Responsible for consultation and analysis that requires broad statistical knowledge, methodological innovation and implementation. Provide consultation and reviews of statistical plans and clinical protocols. The key objective is to provide leadership and support in the use of efficient statistical methods throughout organization in areas such as clinical studies and scientific research.

Responsibilities:
  • Responsible for consultation and analysis that requires broad statistical knowledge, methodological innovation and implementation. Provide consultation and reviews of statistical plans and clinical protocols. The key objective is to provide leadership and support in the use of efficient statistical methods throughout organization in areas such as clinical studies, scientific research and clinical evidence.
  • Position Responsibilities Provide leadership and directs the design, development, modification and evaluation of a statistical infrastructure to expedite the operation and evaluation of clinical trials.
  • Oversees the design and monitors the statistical analysis as well as the development of tracking systems to determine the efficiency of clinical trials.
  • Review and advise on statistical plans in clinical study protocols.
  • Develop biostatistics and SAS programming policies, guidelines and procedures.
  • Evaluate statistical aspects of clinical studies: design, conduct and analysis.
  • Examine methodology, with respect to the study objectives, and regulatory requirements.
  • Review and advise on clinical study and clinical portions of regulatory submissions.
  • Evaluate and problem solve to minimize threats to data integrity.
  • Work with regulatory authorities and industry work groups on biostatistics issues.
  • Ensure cooperation with FDA/Industry task forces on biostatistics issues.
  • Advise in preparation for FDA and other panel meetings and presentations.
  • Advise teams for regulatory (e.g., FDA, PMDA) reviews, responses and interactions.< /SPAN>
  • Oversee the coordination and communication of biostatistics activities and news.
  • Participate in biostatistics and methods educational conferences and meetings.
  • Lead and mentor biostatistics staff involved in SAS programming group and database development.
  • Ensure the effective integration of programming and database development and develop and expand staff capabilities in biostatics and clinical study design/analysis methods.
  • Provide biostatistics services and consultation on complex programs.
  • Provide ad hoc training sessions upon request and as needed.
  • Participate in leading external biostatics initiatives (e.g., conferences, forums).
  • Keep up to date with leading edge biostatics methods and research design issues.
  • Manages budget and staff in accordance with the function’s annual operating plan (AOP) and the organization’s performance management standards.

Requirements:
  • PhD in Biostatistics or MD
  • 10 – 15+ years experience in the design, execution, data management, analysis and reporting of clinical trials
  • Consulting and work on a wide range of clinical studies pre- and post-market
  • 7+ years device industry experience including PMA and IDE submissions
  • 10+ years industry experience with devices and/or pharmaceuticals
  • Interactions with regulatory authorities representing biostatics expertise
  • Advanced applied statistical skills including: Bayesian methods, group sequential and cross-over designs, frequentist and Bayesian adaptive designs, survival analysis, regression modeling, interim analyses, longitudinal analyses, missing data strategies.
  • Knowledge of regulatory requirements governing clinical trials
  • Experience interacting and negotiating with FDA and other regulatory agencies and panels
  • Experience developing and interacting with Data Safety Monitoring Boards, Adverse Events Committees, Clinical Events Committees
  • Expertise in state-of-the-art data manipulation and statistical analyses.
  • Advanced problem-solving and critical thinking skills
  • Must be able to identify and evaluate fundamental problems for major functional areas through assessment of intangible variables. Erroneous decisions will have a long tem effect on the compan y’s success.
  • Ability to interact internally and externally with executive level management requiring negotiation of extremely difficult matters to influence policy making bodies both internally and externally.
  • Combination device experience a strong plus
  • Knowledge of OUS regulatory requirements governing clinical trials
  • Experience with international clinical studies
  • Cost-effectiveness and retrospective claims data research
  • Experience with process validation statistical controls
  • Project management in a matrix environment: facilitation and negotiation; time/resource management; drive to clear objectives
  • Team oriented

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