The Lead Clinical Biostatistician candidate 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. This candidate will possess the skills needed to conduct statistical analyses with the highest level of scientific integrity, while meeting timelines and budgets. The ideal candidate will have strong work ethics and interested in building a career in biotech/biopharma. A successful candidate will be a motivated, self-starter with proven ability to follow through. The Lead Clinical Biostatistician will work closely with the Executive Scientific Director as well as additional clinical and regulatory team members to meet goals and deadlines. A wide degree of creativity and latitude is expected. Some travel will be required for this role. Must have excellent oral and written communication skills.
The candidate will be completely aligned with the four fundamental pillars of Landos’ entrepreneurial and efficient corporate culture: 1) Be bold and decisive, 2) Never give up, 3) Be solution-oriented, and 4) Do the impossible.
- 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.
- Conducting power calculations in preparation for clinical trials.
- 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 related parties 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.
- Responsible for multiple projects and must work both independently and in a team environment.
- Other tasks and responsibilities as needed.
- Maintains the strictest confidentiality of all activities.
- Team player, engendering credibility and confidence within and outside the company.
- Faithfully performs any other tasks requested by the Chairman, President & CEO.
- Act in accordance with Landos’ policies and in alignment with the corporate culture.