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 seniorlevel professional (Director/Sr. Director) who is comfortable wearing multiple hatsproviding strategic input while also handling handson 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 earlyphase 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 nonstatistical 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 crossfunctional teams to analyze data and provide insights that drive decisionmaking and strategy.
Author statistical analysis plans (SAPs) and review data outputs from the programming team.
Provide strategic input while also being comfortable performing handson 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 earlyphase 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 deadlinedriven environment.
Excellent communication skills with the ability to effectively convey statistical concepts to multidisciplinary teams and stakeholders.
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