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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 — United States Remote
Lead statistical work across Phase I–IV clinical trials for a sponsor-dedicated pharmaceutical program. Use SAS, R, and advanced analytics from protocol development through final reporting.
Description
- Independently direct statistical activities for assigned Phase I–IV clinical trials, from protocol design through results reporting.
- Represent Statistics on cross-functional trial and potential indication or project teams while partnering with stakeholders across functions.
- Oversee internal programming work and CRO deliverables for assigned trials and related activities.
- Lead or support statistical work involving safety reporting, ISS/ISE analyses, health-authority questions, and publications.
- Apply SAS and/or R to quality-control datasets and deliverables, conduct inferential analyses, build models and simulations, and perform exploratory analyses.
- Participate in additional initiatives for the company or sponsor.
- Provide guidance and oversight to junior statisticians as needed.
- Work fully embedded with a single pharmaceutical client through a sponsor-dedicated program.
Requirements
- Bachelor’s degree in statistics or a related field.
- At least 9 years of experience supporting clinical trials in the pharmaceutical or biotechnology industry.
- Proven ability to work independently, take initiative, and lead with flexibility and creativity.
- Strong attention to detail, quality orientation, interpersonal and communication skills, innovation, and collaborative working style.
- SAS programming experience for quality control of critical outputs and efficacy and safety tables, with close collaboration with programmers.
- Working knowledge of R programming, including R Shiny, and Python.
Benefits
- Ongoing training, development, and professional support.
- Substantial opportunities for professional advancement.
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