4DMT - 4D Molecular Therapeutics

4DMT, or 4D Molecular Therapeutics, is a biopharmaceutical company that develops gene therapies for genetic diseases. The company emphasizes innovation, collabo

Director, Statistical Programming

DirectorDirectorFull TimeRemoteLeadCompany Site

Location

United States

Posted

37 days ago

Salary

$228K - $256K / year

Seniority

Lead

Bachelor Degree17 yrs expEnglishGoogle Cloud PlatformSQL

Job Description

• 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.

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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