The Lead Biostatistician 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 a Biostatistics Manager or higher role.
- 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.
- 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.
- Assist in the preparation and documentation of results to support trial reports and publications.
- A Master’s degree in Statistics, Biostatistics, or Applied Mathematics with at least 6 years of experience OR a PhD with at least 4 years of experience performing statistical analyses in a regulated environment, preferably medically related including FDA, GCP or other relevant areas.
- Demonstrated technical experience in preparing statistical deliverables on time.
- Thorough understanding of descriptive statistics, power/sample size analysis, hypothesis testing, parametric, non-parametric, and multivariate statistical tests is required.
- Ability to assist in selecting and defining independent and dependent variables in the field of application is preferred.
- Ability to contribute to strategic planning
- Experience with survival analysis, longitudinal data analysis, and other current, innovative statistical methodologies is required.
- Knowledge of Bayesian statistics OR meta-analyses is preferred
- A thorough understanding of covariate analyses is required
- Excellent verbal and written communication skills are required
- Knowledge of Microsoft Word is required
- Proficiency in SAS is required
Familiarity with other statistical packages for handling smaller datasets and power analyses is preferred.
Interested and qualified candidates are welcome to submit a resume to:
Executive Search Consultant, Medical Device Team