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Role Description
We're seeking a specialized Scientific Manager of Biostatistics with deep expertise in pharmacodynamic (PD) data analysis to join our team on an ad hoc, per-study basis. This is a high-impact, on-call opportunity for a statistician who thrives in early-phase clinical research and wants to contribute strategic value without committing to a full-time role.
The Scientific Manager of Biostatistics is responsible for supporting and advising clients on all aspects of PD data collection and analysis. This role involves:
• Developing the PD analysis sections of the Statistical Analysis Plan (SAP) and corresponding PD shells.
• Consulting with clients on PD analysis strategies and subject allocation.
• Providing statistical design and methodology support for PD-related endpoints.
• Reviewing PD tables, figures, and listings (TFLs) to ensure quality and consistency.
• Collaborating cross-functionally with internal teams and clients.
• Participating in team meetings and strategic planning discussions.
Qualifications
• Master's degree in Statistics, Biostatistics, or a related field (Ph.D. preferred).
• Minimum of 5 years of relevant experience as a statistician, with a focus in pharmacodynamic data.
• Experience with CNS and early-phase studies preferred.
• Prior CRO experience is a plus.
Requirements
• Excellent verbal and written communication skills.
• Professional attitude and strong interpersonal skills.
• Ability to work well with a multi-disciplinary team of professionals.
• Client-focused approach to work.
• Solution-focused and ability to creatively solve problems and resolve issues.
• Ability to take initiative and use sound judgment.
• Ability to acquire and apply knowledge quickly.
• Flexible attitude and an ability to effectively prioritize.
• Deep understanding of clinical research, statistical principles, drug development process, and applicable regulatory guidelines as they relate to complex phase I studies of CNS-acting compounds.
• Strong technical aptitude and expertise in statistical analysis principles specific to PD data.
• Working knowledge of SAS programming.
• Good computer skills (Microsoft Word, Excel, and PowerPoint) and ability to understand and adapt to various information technology (IT) systems.
Experience with Specific Data Types
• VAS (Visual Analog Scales)
• Pulmometry (Lung Function Testing)
• Psychedelic-related data and endpoints
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