Scientific Manager of Biostatistics - Fairfield, CT
2 days ago
Job description
Job Description
Contact: Neisha Camacho/Terra Parsons -
No 3rd party candidates
Scientific Manager of Biostatistics
Strategic, Per-Study Role with Flexibility and Growth Potential
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. While initially fractional, the position may evolve based on study load and team needs—making it ideal for experienced professionals looking to partner deeply without traditional constraints.
Position Summary:
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 SAP and shells for tables, listings, and figures (TLFs), consulting with clients on PD analysis strategies, and ensuring data quality and accuracy through review and validation.
This position requires strong pharmacodynamic (PD) endpoint expertise, including extensive work with subjective measures, VAS pain scales, and biomarker-driven analyses.
Responsibilities:
- Develop the PD Analysis section of the Statistical Analysis Plan (SAP) and corresponding PD shells.
- Consult with clients on PD analysis strategies and subject allocation.
- Provide statistical design and methodology support for PD-related endpoints.
- Ability to apply solid judgment to select and implement appropriate statistical techniques based on study objectives, data characteristics, and regulatory expectations
- Review PD tables, figures, and listings (TFLs) to ensure quality and consistency.
- Collaborate cross-functionally with internal teams and clients.
- Participate in team meetings and strategic planning discussions.
Skills:
- Must be a clear, concise, and effective communicator—able to translate complex statistical concepts into actionable insights for clinical and cross-functional teams.
- Professional attitude and strong interpersonal skills.
- Ability to work well with a multi-disciplinary team of professionals.
- Client-focused approach to work.
- Solution-focus 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.
- Significant Phase I clinical trial experience, including Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study designs, execution, and analysis.
- 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
Education and Experience:
- 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.
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