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.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

SAS programmingSAS/BASESAS MacrosSAS/StatSAS/SQLSAS/GRAPHSAS/ACCESSR programmingclinical trial standardsbiostatistics

Soft Skills

organization skillstime managementattention to detailmulti-taskingwritten communicationverbal communicationteam collaborationanalytical thinkingstrategic thinkinginterpersonal skills