Associate Director, Biostatistics

Role 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.

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

Qualifications

• 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

Skills

• 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

Education

• Advanced degree (M.A./M.S. or PhD) preferred, or equivalent experience

Additional Requirements

• Travel: <5%
• Physical Requirements and Working Conditions:
  • Physical Activity - Repetitive motions: ...
  • Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects
  • Working Conditions - The worker is not substantially exposed to adverse environmental conditions