Senior Biostatistician, Regulatory Submissions
Core
Senior biostatistician supporting regulatory submissions and clinical development strategies for life sciences clients.
Role type
Senior IC biostatistician (regulatory strategy)
Builds
Regulatory submissions (FDA, EMA) and evidence generation strategies
Domain
Life sciences / Clinical development / Regulatory affairs
Required skills
Biostatistics, Regulatory submission expertise, Clinical trial design, Statistical analysis planning (SAP), Data integration and cleaning, Team leadership and mentoring, Programming standards development, Strategic advising
Preferred skills
Pharmaceutical or biotechnology industry experience, Client-facing consulting experience
Technologies
SAS, R, Python (implied by standard biostats tools), Clinical trial data systems
Responsibilities
Apply biostatistical and regulatory expertise to support clinical development and regulatory submissions; Contribute to strategic advising on clinical trial design and analysis strategy; Oversee implementation of statistical analysis plans (SAPs); Manage and mentor teams of analysts; Direct data integration and cleaning across clinical and real-world data sources; Develop tools and programming standards; Communicate findings to technical and non-technical audiences; Contribute to business development and client relationships.
Seniority
Senior, hands-on IC with mentorship responsibilities