Principal Biostatistician - Medical Affairs (FSP)
Core
Provide strategic statistical expertise and oversight for clinical research programmes, including Phase IIIb/IV trials, observational studies, and patient registries to support evidence generation for severe autoimmune disease therapies.
Role type
Principal Biostatistician (Medical Affairs)
Builds
Scientific evidence for transformative therapies in autoimmune diseases
Domain
Biotechnology / Clinical Research / Medical Affairs
Required skills
SAS, R, clinical trial design, statistical analysis planning, post-hoc analysis, regulatory requirements (GCP), scientific writing, data interpretation
Preferred skills
Medical Affairs experience, cross-functional matrix organization experience, publication experience, KOL engagement
Technologies
SAS, R
Responsibilities
Lead or contribute to clinical study design and statistical analysis planning; Develop and review Statistical Analysis Plans (SAPs) and Data Presentation Plans (DPSs); Act as statistical representative on cross-functional teams; Collaborate on scientific manuscripts and conference presentations; Conduct rigorous statistical analyses for business-critical research questions.
Seniority
Principal, strategic oversight & scientific leadership