Statistician (Scientist I)
Core
Apply statistical methods to bioanalytical assay development, qualification, and validation to ensure data integrity and regulatory compliance for gene therapy programs.
Role type
Scientist I (Statistics)
Builds
Bioanalytical assays (potency, ddPCR) and analytical validation protocols for gene therapies
Domain
Biopharmaceuticals / Gene Therapy / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Statistical analysis, experimental design, data interpretation, regulatory compliance documentation, trend analysis, root cause analysis, cross-functional collaboration
Preferred skills
Nucleic acid-based assays (ddPCR, qPCR), protein/cell-based assays (ELISA, flow cytometry), GxP-regulated environments, assay validation and stability studies
Technologies
JMP, SAS, R, Python
Responsibilities
Apply statistical methods to support development, qualification, and validation of bioanalytical methods; Perform statistical analyses for assay validation including linearity, accuracy, precision, and detection limits; Support stability studies through trend analysis, control charting, and regression modeling; Assist in data review, interpretation, and troubleshooting for assay development; Contribute to statistical analysis plans (SAPs), validation protocols, technical reports, and regulatory documentation; Collaborate with cross-functional teams (QC, Analytical Development, Process Development, Regulatory); Support investigations, deviations, and root cause analyses with statistical input; Assist in developing and maintaining data trending and reporting tools; Ensure compliance with regulatory requirements (ICH, USP, FDA)
Seniority
Junior, hands-on IC
