4DMT is looking for a Biostatistician to provide strategic input and technical expertise on statistical methodology to support their research and development organization for assigned projects, specifically focusing on advancing durable and disease-targeted therapeutics.
Requirements
- Good understanding of standards specific to clinical trials such as CDISC, SDTM, and ADaM, MedDRA, WHODRUG
- Knowledge of applicable GCP/FDACHMP//ICH/HIPPA regulations
Responsibilities
- 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
- Provide quality review of outsourced statistical deliverables (including inhouse double programming to QC as needed) and coordinate the inhouse review comments
Other
- Advanced degree (M.A./M.S. or PhD) preferred, or equivalent experience
- A./M.S. with 8+ years, or PhD with 5+ 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
- 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
- Travel: <5%
