Associate Director, Biostatistics

🕒 Yesterday

🇺🇸 United States – Remote

💵 $193k - $212k / year

⏰ Full Time

🟠 Senior

👔 Director

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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, 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

🎯 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 • 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.

🏖️ Benefits

• Equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws. • Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities