Job Description
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. 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 Apply tot his job