Associate Director, Biostatistics

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide statistical expertise and collaborate with various functions on the design and planning of studies, as well as protocol development and statistical methodology/analysis.

• Create statistical analysis plans (SAP), TFL shells, and other analysis specifications for assigned studies.

• Develop randomization schemas for designated randomized studies.

• Conduct data analysis and/or work with in-house or vendor statistical programming to ensure quality analysis according to the SAP and specifications.

• Generate statistical reports summarizing the results of data analysis.

• Ensure proper interpretation of data and analysis results, as well as consistency and accuracy in data presentation for study reports and publications.

• Collaborate with various functions to guarantee robust CRF/EDC development and quality data collection for assigned clinical trials.

• Review outsourced statistical deliverables, including in-house double programming for quality control as necessary, and coordinate in-house review comments.

• Stay updated on industry advancements in biostatistics/statistical programming and apply them to relevant systems and processes.

• Actively participate as a member of cross-functional teams to plan, lead, and execute tasks in support of assigned programs.

• Work closely with cross-functional teams and external vendors.

• Perform additional 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 the biotech/pharmaceutical industry.

• Experience in ophthalmology and/or biologic/gene therapy is advantageous.

• Familiarity with all clinical phases (I, II, III, and IV) is desirable.

• Good understanding of clinical trial standards such as CDISC, SDTM, ADaM, MedDRA, and WHODRUG.

• Knowledge of relevant GCP/FDACHMP/ICH/HIPAA regulations.

• Excellent organizational and time management skills, attention to detail, and the ability to manage multiple tasks in a fast-paced environment with changing priorities and/or conflicting deadlines.

• Outstanding written and verbal communication skills, along with the ability to work effectively as a team player in a cross-functional team environment.

• Travel: <5%.

• Capacity to perform repetitive wrist, hand, and finger motions, including fingering, typing, and talking.

• Ability to engage in sedentary work, exerting up to 10 pounds occasionally and negligible force frequently or constantly.

• Capability to work without significant exposure to adverse environmental conditions.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health, dental, and vision insurance.

• Generous paid time off and holidays.

• Opportunities for professional development and career advancement.

• Collaborative and supportive work environment.