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Clinical Outcomes Solutions is a global consultancy focused on clinical outcome assessment (COA) research for pharmaceutical and biotechnology organizations. Its team develops research strategies and practical solutions for capturing reliable data about patients’ experiences, helping clients address the scientific and regulatory complexities of clinical outcomes work. By bringing the patient voice into research design and evidence generation, the company supports informed care decisions and stronger patient outcomes.
Principal Biostatistician, FSP (Remote, United States)
Lead Phase I–IV clinical trial analyses for Cytel’s pharmaceutical clients, applying advanced statistics, R, SAS, and machine learning. Bring expertise in regulatory submissions and study leadership.
Description
- Lead a regional Phase I–IV clinical study.
- Provide statistical and clinical development support for related client trials.
- Advise on processes, clinical development plans, concept sheets, and protocols.
- Oversee work performed by other vendors when needed.
- Develop integrated analytical approaches to extract insights from data sources.
- Use statistical methods, machine learning, and deep learning to generate actionable insights and automate processes.
- Contribute to protocol development, including study design and sample size calculations.
- Explore data to assess study trends, inform scientific decisions, and generate insights throughout development.
- Apply advanced methods, including mixed models and other complex techniques, to efficacy and longitudinal analyses.
- Design and run simulations to assess study designs, operating characteristics, and statistical methods.
- Lead or contribute to efficacy analyses and interpretation of primary and secondary endpoints.
- Review CRFs and data review guidelines; prepare Statistical Analysis Plans, including analysis dataset and TLF specifications.
- Conduct statistical analyses and interpret the results.
- Lead study activities as needed and guide cross-functional teams on statistical strategy.
- Explain statistical methods, assumptions, and decision implications in clear, accessible language.
- Work 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 biostatistics experience supporting clinical trials in the pharmaceutical or biotechnology industry.
- 3–5 years of experience as a study lead working with cross-functional development teams.
- Extensive experience with study design, sample size determination, protocol and SAP development, efficacy analyses, and clinical study reports, including integrated regulatory submission summaries (ISS/ISE).
- Strong knowledge and practical experience with advanced statistical methods, including mixed models, longitudinal analyses, and simulations.
- Experience conducting exploratory statistical analyses to support clinical development and decision-making.
- Proficiency in R for statistical analyses, simulations, data visualization, and advanced modeling.
- Strong SAS programming skills, including quality checks of key outputs and efficacy and safety tables, and close collaboration with statistical programmers.
- Strong knowledge of ICH guidelines and regulatory expectations.
- Understanding and practical application of CDISC standards for regulatory submissions.
- Experience preparing ADaM specifications and programmatically reviewing analysis datasets.
- Regulatory submission experience (ISS/ISE) is strongly preferred.
- Excellent communication skills, including the ability to explain statistical methods and their implications to technical and non-technical audiences.
- Collaborative approach and commitment to high-quality work under tight deadlines.
- Ability to work in a changing environment, manage ambiguity, and adapt to shifting priorities.
Benefits
- Ongoing training, development, and support.
- Opportunities for substantial professional growth.
- Professional development through staff development opportunities.
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