Director, Statistical Programming

Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.   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 deliveryGENERAL 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.    MAJOR DUTIES & 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.   QUALIFICATIONS:   Education:   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  Experience:   B.A./B.S. with 17+ years, or M.A./M.S. with 13+ years  Submission   Experience in ophthalmology and/or biologic/gene therapy a plus   Other Qualifications/Skills:  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  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  Travel: <5%    Physical Requirements and Working Conditions:  Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers.

Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.  Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body.

Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.  Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).  Base salary compensation range: $228,000 - 256,000 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.      4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.   Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

4D Molecular Therapeutics is a leading biotechnology company specializing in gene therapy, founded in 2013. The company is at the forefront of developing innovative therapies using cutting-edge technology to address genetic diseases. 4D Molecular Therapeutics is revolutionizing the field of medicine with its groundbreaking approach to gene therapy, offering promising solutions for patients with previously untreatable conditions.