Associate Director, Biostatistics
4D Molecular Therapeutics
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $194,000 - $234,000 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- 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 inhouse double programming to QC as needed) and coordinate the inhouse 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
Requirements
- 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
- 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
- Travel: <5%
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
statistical analysisstatistical methodologydata analysisrandomization schema developmentstatistical reports developmentCRF developmentEDC developmentquality reviewbiostatisticsstatistical programming
Soft skills
organizationtime managementattention to detailmulti-taskingwritten communicationverbal communicationteam playercross-functional collaboration