Lead product-level biostatistics tasks including regulatory interactions and filings, ensuring statistical integrity.
Contribute to study design, sample size determination, and author/review statistical analysis plans and TFL specifications.
Mentor junior team members and collaborate cross-functionally to meet product deliverables and timelines.
Ultragenyx is a biopharmaceutical company focused on developing life-changing treatments for rare diseases. The company fosters a supportive, inclusive culture emphasizing learning and growth, enabling employees to thrive professionally and personally.
Serve as subject matter expert defining gold standard for AI-generated clinical content.
Share knowledge about day-in-the-life working with data for regulatory submissions.
Identify realistic sources of variance or data corruption in study data.
Edison Scientific builds and commercializes AI agents for science to accelerate scientific discovery. They are assembling a small team of top researchers and engineers across AI and biology to build an AI scientist.
Lead the biometrics team including statisticians, data managers, and statistical programmers at a program level, providing strategic input for clinical development.
Author and develop Statistical Analysis Plans (SAPs), contribute to trial designs, protocol development, and sample size calculations, and oversee vendor deliverables.
Interact with global health authorities, contribute to regulatory submissions, and coordinate statistical analyses for safety updates and ad hoc requests.
Spyre Therapeutics is a clinical-stage biotechnology company developing next-generation long-acting antibodies to redefine the standard of care for inflammatory bowel disease and rheumatic diseases. As a growing company, they offer a fast-paced, dynamic environment where you help shape the culture and contribute broadly to meaningful medicines.
Provides statistical consulting, study design, and data analysis for clinical trials.
Communicates complex statistical concepts to non-statistical stakeholders and clients.
Supports business development, thought leadership, and scientific publications.
Alimentiv is a clinical research organization that provides biostatistical and clinical services to pharmaceutical and biotech clients. They have a Statistical Center of Excellence and offer a remote-based role with a focus on innovation and regulatory compliance.
Maintains responsibility for all assigned biostatistics duties within clinical studies, including acting as study lead for multiple or complex studies.
Reviews and develops clinical program designs, protocols, and statistical analysis plans, ensuring high-quality and valid content.
Provides mentoring to junior statisticians and represents the biostatistics function in internal and external meetings and audits.
Ergomed Group is a rapidly expanding full-service mid-sized CRO specialising in Oncology and Rare Disease. Since 1997, the company has grown organically with operations in Europe, North America and Asia, fostering a true international culture that values employee experience, well-being, and work-life balance.
Provide expert knowledge on day-to-day clinical pharmacology workflows for regulatory submissions.
Identify common tasks and problems where AI can add value in pharmacology workflows.
Generate and review ground-truth artifacts to evaluate AI platform outputs for regulatory-grade quality.
Edison Scientific builds and commercializes AI agents for science to accelerate scientific discovery. They are assembling a team of top researchers and engineers across AI and biology to build an AI scientist, fostering a fast-moving, mission-driven culture.
Serve as subject matter expert defining gold standard for regulatory content on an AI platform.
Ensure outputs reflect current agency expectations and are ready for global submission.
Work flexibly 5–20 hours per week in a remote, US-based role.
Edison Scientific builds and commercializes AI agents for science. They are assembling a team of top researchers and engineers across AI and biology with a fast-moving, mission-driven culture.