Associate Director, Biostatistics
About The Position
4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery GENERAL SUMMARY: The Associate Director, Biostatistics provides strategic input and technical expertise on statistical methodology to lead assigned projects. They will participate as active members of a cross-functional team to plan, lead and execute the tasks required to support the assigned programs. The incumbent will collaborate closely with cross‑functional teams and external vendors.
Requirements
- 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
- 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
Nice To Haves
- Experience in ophthalmology and/or biologic/gene therapy a plus
- Experience with all clinical phases (I, II, III, and IV) is desirable
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
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
101-250 employees
