4DMT, or 4D Molecular Therapeutics, is a biopharmaceutical company that develops gene therapies for genetic diseases. The company emphasizes innovation, collabo
Director, Statistical Programming
Location
United States
Posted
37 days ago
Salary
$228K - $256K / year
Seniority
Lead
Job Description
Job 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.
Benefits
- Base salary compensation range: $228,000 - 245,000
- Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.
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