Associate Director, Biostatistics

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $197k - $217k / year

⏰ Full Time

🟠 Senior

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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4D Molecular Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

💼 Consulting

🏭 Manufacturing

🧬 Biotechnology

Consulting • Manufacturing • Biotechnology

4D Molecular Therapeutics is a clinical stage biopharma company inventing and developing innovative products to unlock the full potential of genetic medicine, aiming to treat both large market and rare diseases. Utilizing its Therapeutic Vector Evolution platform, the company leverages directed evolution to create customized AAV vectors with superior therapeutic profiles. With a diverse pipeline including five product candidates in clinical trials targeting seven patient populations, 4DMT is committed to addressing challenges in genetic medicine and pursuing potential curative therapies while fostering a collaborative and innovative environment.

📋 Description

• Provide statistical expertise and collaborate with various functions on study design/planning, protocol development, and statistical methodology/analysis • Develop statistical analysis plans (SAP), TFL shells, and other analysis specifications for assigned studies • Develop randomization schemas for assigned randomized studies • Perform data analysis and/or collaborate with in-house or vendor statistical programming to ensure quality analysis per the SAP and specifications • Develop statistical reports summarizing data analysis results • Ensure adequate interpretation of data/analysis results and consistency and accuracy of data presentation for study reports and publications • Collaborate with various functions to ensure robust CRF/EDC development and quality data collection for assigned clinical trials • Review outsourced statistical deliverables, including in-house double programming for QC as needed, and coordinate in-house review comments • Stay abreast of industry developments in biostatistics/statistical programming and apply them to appropriate systems and processes • Participate as an active cross-functional team member to plan, lead, and execute tasks supporting assigned programs • Collaborate closely with cross-functional teams and external vendors • Perform other duties as assigned

🎯 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 • 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 • Excellent organization and time management skills, 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% • Ability to perform repetitive wrist, hand, and finger motions, fingering, typing, and talking • Ability to perform sedentary work, exerting up to 10 pounds occasionally and negligible force frequently or constantly • Ability to work without substantial exposure to adverse environmental conditions