Associate Director, Biostatistics

Emeryville, CA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Attention recruitment agencies: All agency inquiries are vetted through 4DMTs 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 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:

The incumbent will focus on providing strategic input and technical expertise on statistical methodology to support the research and development organization for assigned projects. 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 expertise and collaborate with various functions on study design/planning protocol development statistical methodology/analysis
Responsible for the development of statistical analysis plan (SAP) TFL shells and other analysis specifications on assigned studies
Responsible for the development of randomization schema on assigned randomized studies
Perform data analysis and/or collaborate with statistical programming (inhouse or vendor) to ensure quality analysis conducted per the SAP and specifications
Responsible for the development of statistical reports summarizing the data analysis results
Ensure adequate interpretation of data/analysis results and consistency/accuracy of data presentation for study reports and publications

Collaborate with various functions to ensure robust CRF/EDC development and quality data collection for the assigned clinical trials
Provide quality review of outsourced statistical deliverables (including inhouse double programming to QC as needed) and coordinate the inhouse review comments
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 managements right to assign or reassign duties and responsibilities to this job at any time

QUALIFICATIONS:

Education:

Advanced degree (M.A./M.S. or PhD) preferred or equivalent experience

Experience:

A./M.S. with 8 years or PhD with 5 years in biotech/pharmaceutical industry
Experience in ophthalmology and/or biologic/gene therapy a plus
Experience with all clinical phases (I II III and IV) is desirable

Other Qualifications/Skills:

Good understanding of standards specific to clinical trials such as CDISC SDTM and ADaM MedDRA WHODRUG
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

Travel: <5%

Base salary compensation range: $194000/yr - $234000/yr

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

Attention recruitment agencies: All agency inquiries are vetted through 4DMTs 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 tolera...