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/or real-world data. The successful incumbent will be a member of cross-functional teams and contribute to the strategic and operational decisions for one or multiple therapeutical areas (TAs). He/she will provide statistical support to Medical Affairs, Market Access, Health Economic Outcome Research (HEOR) within CSL Behring.
• Effectively engages as a matrix team member on projects as a strategic partner in the evidence generation and publication strategy
• Advising, planning and execution of exploratory analyses of clinical trial data for publication, Health Technology Assessment (HTA) evaluation and payer negotiation
• Participation in CRO governance; Manage outsourcing operations or work with internal statistical programmers within the responsible projects
• Closely collaborate with key stakeholders 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
• Takes accountability for ensuring timely and high-quality statistical deliverables
• Be responsible for interpreting analysis results and ensuring reporting accuracy
• Develop, assess, and conduct training in basic statistical methods and topics as needed
• Support or lead improvement initiatives within the department, organization and/or pharma industry
• A graduate degree in Statistics, Epidemiology, Data Science or related field is required, Ph.D. preferred.
• At least 6 years (for MS 9 years) of experience in Medical Affairs or other market facing organizations
• Broad understanding and application of innovative 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, etc.)
• Experience with HTA methods and Payer facing analytics, such as economic modeling and indirect treatment comparisons
• Ability to collaboratively work and provide leadership in matrix environment
• Ability to be flexible and adapt quickly to the changing needs of the organization
• Comfortable around M.D.s, both internal and external to the company
• Strong interpersonal and communication skills (verbal and written in English)
• A solutions-oriented and self-motivated mindset
• Hands-on programming skills in SAS and/or R.
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About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
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