Director, Statistical Programming

4D Molecular Therapeutics•Emeryville, CA

4h•$228,000 - $256,000

About The Position

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery GENERAL SUMMARY: The Director of Statistical Programming will focus on applying programming methodology for implementing statistical analyses using SAS for in-house deliverables and performing quality review of outsourced statistical deliverables. They will participate as active members of a cross-functional team to plan, lead and execute the tasks required to support the assigned programs.

Requirements

B.A./B.S. degree in statistics, computer science, or other quantitative science major required
B.A./B.S. with 17+ years, or M.A./M.S. with 13+ years
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 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
Able to run the P21 checks is a plus
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

Nice To Haves

Advanced degree (M.A./M.S.) preferred, or equivalent experience
Experience in ophthalmology and/or biologic/gene therapy a plus
Proficiency in R programming a plus

Responsibilities

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.