Principal Biostatistician, FSP

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee one Phase I-IV clinical study throughout the region

• Offer statistical and developmental support while influencing related client trials

• Provide expertise in clinical development plans, concept sheets, and protocols

• Potentially supervise tasks handled by other vendors

• Develop integrated analytical strategies to extract insights from data sources

• Utilize statistical methods, machine learning, and deep learning algorithms to derive actionable insights and automate processes

• Engage in the creation of study protocols, including discussions on study design and sample size calculations

• Take part in exploratory data analyses to assess emerging study trends, support scientific decisions, and generate insights throughout the development process

• Implement advanced statistical methodologies, such as mixed models and other complex modeling techniques, to facilitate efficacy and longitudinal analyses

• Design and conduct simulation studies to assess study designs, operational characteristics, and statistical methodologies

• Lead and contribute to efficacy analyses and the interpretation of primary and secondary endpoints

• Review CRFs and data review guidelines; create Statistical Analysis Plans, including analysis datasets and TLF specifications

• Conduct statistical analyses and interpret the results

• Lead study activities as needed and provide strategic statistical advice to cross-functional teams

• Present statistical methodologies, assumptions, and the implications of decisions in a clear, non-technical manner

• Collaborate with cross-functional teams and adjust as project priorities change

⛳️ Requirements

• Master's degree in Statistics, Biostatistics, or a related field

• 8-10 years of biostatistical experience supporting clinical trials in the pharmaceutical or biotechnology sectors

• 3-5 years of experience as a Study Lead collaborating with cross-functional development teams

• Extensive experience in study design, sample size determination, protocol development, SAP development, efficacy analyses, and the preparation of clinical study reports, including integrated summaries for regulatory submissions (ISS/ISE)

• In-depth knowledge and practical application of advanced statistical methods, including mixed models, longitudinal analyses, and simulation methodologies

• Proven experience conducting exploratory statistical analyses to aid clinical development and decision-making

• High proficiency in R for statistical analyses, simulations, data visualization, and advanced modeling

• Strong SAS programming skills, including quality control of key outputs, efficacy and safety tables, and close collaboration with Statistical Programmers

• Comprehensive understanding of ICH guidelines and regulatory expectations

• Solid knowledge and application of CDISC standards for regulatory submissions

• Experience in generating ADaM specifications and conducting programmatic reviews of analysis datasets

• Regulatory submission experience (ISS/ISE) is highly preferred

• Exceptional communication skills with the ability to articulate statistical methodologies and their implications to both technical and non-technical audiences

• Strong collaborative attitude with a commitment to delivering high-quality work within tight deadlines

• Capacity to excel in a dynamic environment, manage uncertainty, and adapt to shifting priorities

🏝️ Benefits

• Ongoing training, development, and support

• Significant opportunities for professional growth

• Professional development opportunities through staff development initiatives