Provide statistical expertise and collaborate with various functions on study design/planning, protocol development, statistical methodology/analysis
Responsible for the development of statistical analysis plan (SAP), TFL shells and other analysis specifications on assigned studies
Responsible for the development of randomization schema on assigned randomized studies
Perform data analysis and/or collaborate with statistical programming (inhouse or vendor) to ensure quality analysis conducted per the SAP and specifications
Responsible for the development of statistical reports summarizing the data analysis results
Ensure adequate interpretation of data/analysis results and consistency/accuracy of data presentation for study reports and publications
Collaborate with various functions to ensure robust CRF/EDC development, and quality data collection for the assigned clinical trials
Provide quality review of outsourced statistical deliverables (including in-house double programming to QC as needed) and coordinate the in-house review comments
Stay abreast of industry development in biostatistics/statistical programming fields and apply to appropriate systems and processes
Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time

Advanced degree (M.A./M.S. or PhD) preferred, or equivalent experience
A./M.S. with 7+ years, or PhD with 4+ years in biotech/pharmaceutical industry
Experience in ophthalmology and/or biologic/gene therapy a plus
Experience with all clinical phases (I, II, III, and IV) is desirable
Good understanding of standards specific to clinical trials such as CDISC, SDTM, and ADaM, MedDRA, WHODRUG
Knowledge of applicable GCP/FDACHMP//ICH/HIPPA regulations
Displays excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a fast-paced environment with shifting priorities and/or conflicting deadlines
Excellent written and verbal communication skills and strong team player with demonstrated track record of success in cross-functional team environment.

Associate Director, Biostatistics

Key skills