The Associate Director, Medical Affairs Biostatistics will support product launch and life-cycle management of marketed products by generation of scientifically valid information from clinical trials and real-world data. You will contribute to the strategic and operational decisions for one or multiple therapeutical areas (TAs). You will provide statistical support to Medical Affairs, Market Access, Health Economic Outcome Research (HEOR) within the client .
The Role
Engage as a matrix team member on projects as a strategic partner in the evidence generation and publication strategy
Execution of exploratory analyses of clinical trial data for publication, Health Technology Assessment (HTA) evaluation and payer negotiation
Participate in CRO governance; Manage outsourcing operations or work with internal statistical programmers within the responsible projects
Collaborate with important partners for the design and analysis of registry trials and RWE (Real-world evidence) studies initiated by Medical Affairs, Market Access, and HEOR. Evaluate statistical validity of proposals of those studies and advise on reasonable improvements to ensure the highest quality of published evidence
Take accountability for high-quality statistical deliverables
Interpret analysis results and ensuring reporting accuracy
Develop, assess, and conduct training in basic statistical methods and topics
Your Training & Experience
A graduate degree in Statistics, Epidemiology, Data Science or related field is required, a Ph.D. is preferred.
At least 6 years (for MS 9 years) of experience in Medical Affairs or other market facing organizations
Broad understanding and application of statistical methods for exploratory analyses of clinical data and generating real-world evidence, including causal inference methods for analyzing non-randomized data
Knowledge of clinical data and real-world data source (e.g., healthcare administrative data, electronic health records, disease/patient registries, and related sources)
Experience with HTA methods and Payer facing analytics, such as economic modeling and indirect treatment comparisons
Programming skills in SAS or R.
*Hybrid Schedule*
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Health Care Provider
Industries
IT Services and IT Consulting, Software Development, and Financial Services
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