[Hiring] Director, Biostatistics @4D Molecular Therapeutics

Role Description The incumbent provides strategic statistical input to and oversees all statistical aspects of assigned programs; drives cross-functional collaboration and decision making for program(s); oversees the performance of Contract Research Organizations (CROs); develop and mentor other statisticians. Major Duties & Responsibilities

• Ensures expert level contribution to strategy (design, analysis/synthesis, interpretation and reporting, health authority response, influence and implement publication strategy, quantitative decision making) for critical studies in a program.
• Leads collaborations with clinical, regulatory and other strategic functions to drive quantitative decision making and enables successful impact on robust drug development plans.
• Maintains indication specific standards with respect to key variables, variable definitions, statistical methods, data structures and presentation of results.
• Provides oversight and guidance to staff members within 4DMT and in CROs in completing high quality study deliverables according to agreed timelines following quality standards.
• Leads and/or participates in the development and review of Policies, SOPs and other controlled documents for process improvement and operational efficiency.
• Supports the preparation and validation of statistical analyses for use in regulatory documents and scientific articles. Support internal ad-hoc and exploratory analysis.
• Plays a critical role in shaping team development and contributing to departmental strategy.
• Stays abreast of and contributes to scientific advances in the field.
• Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Qualifications

• Education: M.S. required, PhD preferred.
• Experience: 8+ years of pharmaceutical industry experience with a PhD, or 10+ years with an MS.
• Hands-on familiarity with common and advanced statistical methodology.
• Hands-on experience working with CDISC standards and programming based on raw datasets, SDTM, and ADaM datasets.
• Strong knowledge of SAS programming concepts and techniques in the pharmaceutical; proficiency in tools such as SAS, EAST, and nQuery.
• Knowledge/experience of Retinal development, including global regulatory requirements and design and analysis of non-inferiority trials.
• Travel: Apply tot his job

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