The Principal Biostatistician Medial Affairs Biostatistics leads the statistical support for product launch and life-cycle management of marketed products to one or more products within a therapeutic area (TA). The Principal Biostatistician implements the statistical strategies for the secondary analysis of clinical trial data and non-interventional real-world studies led by Medical Affairs, Market Access, Health Economic Outcome Research (HEOR) and is accountable for the statistical deliverables.
• Input to statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for non-interventional real-world studies
• Advising, planning and execution of exploratory analyses of clinical trial data for publication, Health Technology Assessment (HTA) evaluation and payer negotiation
• Manage outsourcing operations or work with internal statistical programmers within the responsible projects. Ensure timeliness and quality of deliverables by CRO. Conduct reviews of deliverables to ensure quality
• Support Biostatistics interactions with HTA Agencies (e.g., UK NICE) and Payers
• Takes accountability for ensuring timely and high-quality statistical deliverables
• Be responsible for interpreting analysis results and ensuring reporting accuracy
• 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 4 years (MS 7 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
• 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
• 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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