- Provides strategic, scientific and statistical expertise as a core member of Translational Medicine Teams.
- Provides statistical expertise and guidance on the scientific and statistical strategy and execution of the strategy for the development of candidate predictive biomarker(s) and precision medicine.
- Partners with Biomarkers Leads and Translational Sciences groups to develop and optimize biomarker assays, assess and optimize biomarker technology platforms, including technology platform due diligence.
- Partners with Biomarkers and Precision Medicine in discovering potential pharmacodiagnostic biomarkers to provide statistical expertise and rigor in the design of studies, statistical analysis and inferences, including control for multiplicity and mitigation for overfitting when applicable to biomarker signature efforts.
- Partners with GBS Leads and protocol statisticians in reviewing protocols and statistical analysis plans (SAP) and providing biomarker/diagnostic expertise and guidance during SAP development.
- Scientific and strategic input into pre-Investigational Device Exemption and HA documents and therapeutic program milestone presentations containing pharmacodiagnostic plans.
- Providing scientific and strategic input during development and execution phase of diagnostic registration and regulatory reviews, including interactions with diagnostic partner companies and Health Authorities.
- Contributes to the evolving pharmacodiagnostics and precision medicine statistical landscape internally and externally by providing education internally and attending and presenting at workshops and meetings and sharing the learnings.
- Ph.D. or equivalent in statistics or related field.
- > 12 years of clinical, pharmacodiagnostics, biomarkers discovery and development, regulatory interactions, filing support experience.
- Expert knowledge of the precision medicine literature and statistical approaches to discovering, developing and validating companion diagnostics and biomarkers, including regulatory requirements.
- Strong technical skills, including but not limited to general linear and mixed models, survival analysis, high-dimensional data analysis, bayesian statistics, design of experiments, statistical methods for biomarker assay development and validation and joint evaluation of therapies for efficacy and safety with biomarkers for prediction and classification.
- Excellent verbal and written communications skills.
- Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization, and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement.