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.
Trial Design. Conducting power calculations in preparation for clinical trials. Contribute statistical considerations to overall trial design schema. Develop innovative strategies to maximize design efficacy and robustness. Perform sensitivity and sub analyses from historical data to project proper assumptions for ensuing phases of clinical development. Develop specifications for analysis populations, handling of missing data, and other considerations. Develop and draft estimands for the trial according to FDA guidelines.
Statistical Analysis. Design and execute statistical plans independently for all phases of clinical studies, assuming a leadership role in creating strategy for study design and analyses. Draft statistical analysis plans and statistical design questions to regulatory agencies. Provide guidance on standards, processes, and technical direction within the biostatistics team. Develop, review, validate, and execute SAS programs for analysis of clinical data.
Study Conduct. 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. Assist with preparation of documentation for IRB/Ethics Committee submissions. Provide statistical reports for data quality/performance metrics.
Vendor Management. Participate in vendor evaluation, selection, contracting, and oversight for statistical and programming deliverables. Interface with the data management and biometrics teams for coding of data, including SDTM and ADAM. Coordinate test transfers and data transfers. Provide a statistical review of shell and final tables, listings, and figures.
Technical Research and Communications. May oversee production of presentation materials for presentations at professional meetings. Stay current with statistical methodology in clinical trial design and analysis. Assist Clinical Research with literature reviews and other activities pertaining to understanding industry statistical methods and standards. Assist in the preparation and documentation of results to support trial reports and publications. Interface with related parties to assist in drafting peer-reviewed journal articles. May assist in presenting information at professional meetings.
Teamwork. Act in accordance with Landos’ policies and in alignment with the corporate culture. 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. Interact with R&D, Biometrics, Data Management, Regulatory, and Clinical staff to define and clarify project requirements. Act as a statistical consultant to the business units and external customers on statistical issues. May oversee the statistical deliverables produced by lower-level biostatisticians or external consultants. Responsible for multiple projects and must work both independently and in a team environment.
Other tasks and responsibilities as needed.
Required Knowledge, Skills, and Abilities:
- 1-10 years handling clinical data
- Thorough knowledge of statistical analysis and its role in the drug development process
- Analytical software: SAS, R, PRISM, Python, Excel
- Experience of all stages of a clinical trial and vendor oversight
- Demonstrated knowledge of ICH/GCP guidelines as they relate to clinical data
- Thorough understanding of CDISC CDASH and SDTM standards
- Experience working with a globally distributed team
- Ability to work on and solve complex problems.