Associate Director, Biostatistics

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

📋 Description

• Offer statistical expertise and collaborate with multiple functions on study design and planning, protocol formulation, and statistical methodology and analysis.

• Accountable for creating the statistical analysis plan (SAP), TFL shells, and other analysis specifications for assigned studies.

• Responsible for devising randomization schemas for designated randomized studies.

• Conduct data analysis and/or work together with statistical programming (either in-house or with vendors) to guarantee quality analyses are performed per the SAP and specifications.

• Tasked with developing statistical reports that summarize the results of data analyses.

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

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

• Provide quality reviews of outsourced statistical deliverables (including in-house double programming for quality control as necessary) and coordinate the in-house review feedback.

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

• Perform other duties as assigned; nothing in this job description limits management's right to assign or reassign duties and responsibilities at any time.

⛳️ Requirements

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

• A M.S. with over 7 years of experience or a PhD with more than 4 years in the biotech or pharmaceutical industry.

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

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

• Strong understanding of standards applicable to clinical trials such as CDISC, SDTM, ADaM, MedDRA, and WHODRUG.

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

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

• Excellent written and verbal communication skills, along with a proven ability to work effectively as part of a cross-functional team.

🏝️ Benefits

• Equal employment opportunities for all employees and applicants 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.