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 — India Remote
Lead statistical strategy and execution for Phase I–IV clinical trials supporting pharmaceutical clients. Apply SAS, R, and advanced analytical methods from protocol development through reporting.
Description
- Independently lead statistical work for assigned Phase I–IV clinical trials, from protocol design through final results reporting.
- Serve as the Statistics representative on cross-functional trial and, where applicable, indication or project teams.
- Partner effectively with stakeholders across functions.
- Oversee internal programming work and CRO contributions for assigned clinical trials.
- Support or lead safety reporting, ISS/ISE analyses, health-authority responses, and publications.
- Use SAS and/or R to quality-check datasets and deliverables and perform inferential analyses, modeling, simulation, and exploratory analyses.
- Contribute to initiatives led by Cytel or its sponsors.
- Provide guidance and oversight to junior statisticians.
- Develop integrated analytical approaches that combine statistical methods, machine learning, and deep learning to generate actionable insights and automate recurring processes.
Requirements
- Bachelor’s degree or higher in statistics or a related field.
- At least nine years of experience supporting clinical trials in the pharmaceutical or biotechnology industry.
- Ability to work independently while showing initiative, flexibility, and effective, innovative leadership.
- Strong attention to detail and quality, along with excellent interpersonal and communication skills and an innovative, collaborative approach.
- SAS programming expertise for quality-checking critical outputs and efficacy and safety tables, with the ability to work closely with programmers.
- Working knowledge of R programming, R Shiny, or Python.
Benefits
- Ongoing training, development, and professional support.
- Meaningful opportunities for professional advancement.
- Autonomy and ownership over your work.
- Support from Cytel while working within a pharmaceutical client engagement.