The Senior Statistical Scientist, Biostatistics drives the statistical strategy for one or more indications within a therapeutic area within Clinical Research & Development to ensure robust, evidence based decision making; operational and execution excellence – to enable seamless implementation of the drug development plans. He or she facilitates the discussion and ensures implementation of modern and innovative trial designs, statistical models, and analysis methodologies that optimize the drug development program in terms of risk, cost and timelines for each indication. As a strategic partner she or he provides statistical strategies for clinical development plans and for global regulatory submissions, and contribute to the drug development decisions with internal and external partners. This role has global responsibilities with potential for matrix management, participation in global teams, and interacts with regulatory agencies in multiple countries.
Main Responsibilities and Accountabilities:
Lead the Biostatistics contributions to, and facilitate the direction of robust clinical development planning, seamlessly integrating all relevant technical and indication-specific knowledge.
Actively participates in the study execution team and/or the clinical development team to provide statistical insight into execution of clinical development, to ensure study conduct leads to a statistically sound and robust data package, maximise probability of program success with objective and transparent clinical program assessments using quantitative risk/probability of success assessments.
Provides statistical scientific consulting, and quantitative contributions to planning, execution and reporting of clinical trials and regulatory/submission strategy and related documents: (e.g.: SAP, Protocol, CSRs, integrated summaries, and responses to HA questions).
Drive the full integration of modern aspects of drug development including model-based drug development and statistical methodologies in collaboration with partners.
Provide technical statistical expertise and leadership within the framework of the indication.
Collaborate with, direct and monitor the work of CRO statisticians and statistical programming. Support and develop the relationships with CROs statistical functions. Perform acceptance checks of CRO deliverables.
Responsibility for statistical parts of CRO tendering process and work orders involving assigned therapeutic area.
Support and lead infrastructure / process / scientific consulting improvement initiatives and related standards
Position Qualifications and Experience Requirements: Provide hiring requirements for the specified position, including educational, experiential, and competency requirements necessary for the position.
PhD in Statistics (or equivalent), plus undergraduate degree in a quantitative field.
At least 5 years experience in Clinical Development in a Pharmaceutical or Biotechnology setting
Proven expert scientific leadership skills demonstrated in successfully executing clinical trials and programs
Strong interpersonal and communication skills ( verbal and written) bridging scientific and business needs – integrating quantitative sciences, strong drug development knowledge
Fluent in English (oral and written).
Natural modern leadership style building partnerships and collaborative environments
Thorough understanding of drug development from pre-clinical phases through to post-marketing, including for small orphan indications and hard-to-study indications.
Desirable to have an understanding of epidemiology, modern clinical safety and pharmacovigilance, pharmacokinetics and –dynamics,
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