Contact: Neisha Camacho/Terra Parsons - teamnt@penfieldsearch.com
No 3rd party candidates
Overview: We are seeking a highly skilled and independent Biostatistician with a strong background in statistical analysis within the field of metabolic studies, particularly obesity (Not Mandatory). This is a contract position that allows for remote work.
The ideal candidate will be a senior-level professional (Director/Sr. Director) who is comfortable wearing multiple hats—providing strategic input while also handling hands-on operational duties. This individual will play a critical role on the core team, actively contributing to the "first in human" study and working on multiple compounds.
Key Responsibilities:
- Collaborate with clinical teams to design and analyze statistical methodologies for early-phase clinical trials (Phase I and Phase II) targeting metabolic disorders, particularly obesity.
- Conduct sample size calculations, power analyses, and perform simulations to support study design and implementation.
- Prepare and present statistical reports and visualizations that clearly communicate complex statistical concepts to non-statistical audiences.
- Provide statistical input in protocol development, including study design and methodology, ensuring alignment with regulatory standards.
- Contribute to the preparation of regulatory submissions and publications, ensuring accuracy and clarity in statistical reporting.
- Engage with cross-functional teams to analyze data and provide insights that drive decision-making and strategy.
- Author statistical analysis plans (SAPs) and review data outputs from the programming team.
- Provide strategic input while also being comfortable performing hands-on operational duties.
- Collaborate with both junior and senior colleagues, providing mentorship and facilitating effective communication across all levels.
Qualifications:
- Preferred - Ph.D. in Biostatistics, Statistics, or a related field.
- Proven experience with R programming for statistical analysis and data visualization.
- Proficiency in SAS programming.
- Demonstrated expertise in study design, sample size calculations, and simulation methodology.
- Experience in early-phase clinical trials (Phase I and Phase II) across multiple therapeutic areas; specific experience in metabolic disorders preferred.
- Strong organizational skills and the ability to manage multiple projects in a deadline-driven environment.
- Excellent communication skills, with the ability to effectively convey statistical concepts to multidisciplinary teams and stakeholders.
