Director, Statistical Programming

Role Overview

• Provide statistical programming leadership for an assigned indication that may consist of multiple clinical trials
• Work closely with biostatisticians to review the SAP, and responsible in the development of data/analysis program specification based on the SAP
• Maintain complete and auditable programming documentations for analysis of clinical trials
• Contribute to the development, documentation and maintenance of reusable programming code library
• Collaborate with IT to set-up/maintain the statistical computing infrastructure (e.g., SAS server)
• May act as a biostatistician on small-scale projects
• Collaborate with various functions to ensure robust CRF/EDC development, and quality data collection for the assigned clinical trials
• Oversee the biometrics vendors to ensure the prompt and quality statistical deliverables
• Provide quality review of outsourced statistical deliverables (including inhouse double programming to QC as needed) and coordinate the inhouse review comments
• Contribute to the development of functional-level standards, SOPs, and work instructions and templates
• 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

• B.A./B.S. degree in statistics, computer science, or other quantitative science major required
• Advanced degree (M.A./M.S.) preferred, or equivalent experience
• B.A./B.S. with 17+ years, or M.A./M.S. with 13+ years
• Experience in ophthalmology and/or biologic/gene therapy a plus
• Strong SAS programming skills required with proficiency in SAS/BASE, SAS Macros, SAS/Stat and ODS (proficiency in SAS/SQL, SAS/GRAPH or SAS/ACCESS is a plus)
• Proficiency in R programming a plus
• Proficiency in Microsoft Office Apps, such as WORD, EXCEL, and PowerPoint (familiar with the “Chart” features in EXCEL/PowerPoint a plus)
• Good understanding of standards specific to clinical trials such as CDISC, SDTM, and ADaM, MedDRA, WHODRUG
• Experience with all clinical phases (I, II, III, and IV) is desirable
• Experience with BLA/IND submissions is strongly desirable
• Good understanding of regulatory requirements for submission-related activities (e.g., CDISC, CDASH, eCTD) and CRT packages (e.g., XPTs Define/xml, reviewer’s guide, analysis metadata report, executable programs) is desirable
• 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.
• Proven conceptual, analytical and strategic thinking.
• Good interpersonal and project management skills.
• Proactively identifies risks, issues, and possible solutions.

Tech Stack

• Google Cloud Platform
• SQL