Principal Biostatistician

The Principal Biostatistician will be responsible for developing strategy and designing statistical analysis plans for regulated and non-regulated studies; performing statistical analyses; creating reports intended for internal distribution and regulatory submissions; creating internal presentations and white papers; interfacing with surgeons to assist in drafting peer-reviewed journal articles; overseeing vendors and contractors; and contributing to studies that are focused on economic outcomes. 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 Leader.

RESPONSIBILITIES:

  • 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.
  • Assist in developing strategy for clinical trials and research aimed at healthcare economic issues.
  • Design and execute statistical plans for all phases of clinical studies independently, assuming a leadership role in creating the 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, or submissions aimed at other stakeholders where outcomes are economic in nature.
  • 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).
  • Participate in evidence generation strategy discussions with clinical and cross-functional partners.
  • 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.
  • Interpret statistical analyses and publications in preparation of new device applications to regulatory bodies.
  • 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 and Healthcare Economics with literature reviews and other activities.
  • Oversee production of presentation materials for professional meetings, and may assist in presenting information at these meetings.
  • Oversee the statistical deliverables produced by lower-level biostatisticians or external consultants.
  • Stay current with statistical methodology in clinical trial design and analysis.
  • Demonstrate technical experience in preparing statistical deliverables on time.
  • Demonstrate strong knowledge of products/therapeutic areas being evaluated.
  • Clarify descriptive statistics, hypothesis testing, non-parametric, and multivariate statistical tests.
  • Assist in selecting and defining independent and dependent variables in the field of application.
  • Contribute to strategic planning.
  • Address survival analysis, longitudinal data analysis, and other current, innovative statistical methodologies.
  • Demonstrate knowledge of Bayesian statistics and meta-analyses.
  • 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.

QUALIFICATIONS:

  •  A Master’s degree in Statistics is required, PhD preferred.
  • At least 8 years of experience (or PhD with 6 years) in clinical research is required.
  • Experience with Medical Device, Pharmaceuticals, or FDA is preferred.
  • Knowledge and a thorough understanding of covariate analyses is required.
  • Consistent demonstration of advanced statistical application and personal development in statistical methodology is required.
  • Travel up to 10% is required.

 

William McQueen

Executive Search Consultant, Medical Device Team

wm.mcqueen@thelrjgroup.com

914-505-7381 Google Voice, (727) 846-3007 (Cellular)