Director, Statistical Programming

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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 Companys 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 Companys 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 Companys 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 :

TheDirector ofStatistical Programmingwill focus on applying programmingmethodologyfor implementing statistical analyses using SAS for in-house deliverables and performing quality review of outsourced statistical willparticipateas active members of a cross-functional team to planleadand execute the tasksrequiredto support the assigned programs.

MAJOR DUTIES &RESPONSIBILITIES :

• Provide statistical programmingleadershipfor an assignedindicationthat may consist ofmultiple 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 developmentdocumentationand maintenance of reusable programming code library
• Collaborate with IT to set-up / maintainthe 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 toappropriate systemsand processes
• Other duties as assigned nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time.

QUALIFICATIONS : Education :

Experience :

Other Qualifications / Skills :

Travel :

Physical Requirements and Working Conditions :

Base salary compensation range : $228000 - 256000

Pleasenotethe base salary compensation range and actual salary offered to the final candidatedependsonvarious factors : candidatesgeographical 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

Required Experience :

Director

Key Skills

Aviation Safety,Arabic Speaking,Information Technology Sales,JQuery,Db2

Employment Type : Full Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 228000 - 256000