Responsibilities:

• Contribute to the preparation of study protocols, development of statistical analysis plans, implementation of innovative statistical methods, writing programs to execute analyses, and assisting with the interpretation and dissemination of findings
• In collaboration with cross-functional teams, lead and support reporting of clinical studies and RWE studies for regulatory submissions, health technology assessments (HTAs), and publications
• Assist a variety of Clinical Development and Medical Affairs activities in developing abstracts, publications, and managing ad-hoc requests
• Lead and support future studies that involve claims databases (e.g., MarketScan, Pharmetrics, etc), EMR/EHR (e.g., Flatiron’s oncology EHR databases), and registries
• Stay abreast of industry and academic developments in the Statistical Genomics and real-world evidence generation and apply to clinical study design and analysis
• Present some of the state-of-the-art statistical methodologies and issues via various departmental and company-wide meetings

Preferred Qualifications:

• PhD in Biostatistics or related field with 5+ years (or MS with 8+ years) in academia or industry experience including at least 3 years of experience in the fields of RWE and Epidemiology.
• Molecular diagnostics or pharmaceutical industry experience preferred
• Familiarity with traditional performance metrics of clinical diagnostic tools
• Strong knowledge of theoretical and applied statistics, particularly in the fields of epidemiology, health economics and outcomes research (HEOR), and RWE (e.g., propensity score matching/weighting, longitudinal data analysis, difference-in-differences estimation, synthetic/historical control arms, indirect treatment comparisons, network meta analysis, count data regressions, parametric/non-parametric survival analysis (e.g., competing risks models, multi-state models, frailty random effects models, etc)
• Outstanding verbal, writing, and presentation skills with a strong ability to influence and communicate effectively throughout all levels of the organization and externally
• Demonstrated success leading the statistical portion of post-launch product evaluation in the diagnostic/IVD or pharmaceutical industry is a plus
• Knowledge of applicable regulatory rules and guidelines, not limited to ICH, GCP, HIPAA, NICE, and other RWE guidelines
• Experience programming in R or related programming environment (e.g. SAS)