Skills

Research Programming Process Improvement Recruitment Team Development

Job Specifications

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 delivery

General Summary

The incumbent provides strategic statistical input to and oversees all statistical aspects of assigned programs; drives cross-functional collaboration and decision making for program(s); oversees the performance of Contract Research Organizations (CROs); develop and mentor other statisticians, act as Head of Biostatistics when needed.

MAJOR DUTIES & RESPONSIBILITIES:

Ensures expert level contribution to strategy (design, analysis/synthesis, interpretation and reporting, health authority response, influence and implement publication strategy, quantitative decision making) in the global development program
Leads collaborations with clinical, regulatory and other strategic functions to drive quantitative decision making and enables successful impact on robust drug development plans
Provides oversight and guidance to staff members within 4DMT and in CROs in completing high quality study deliverables according to agreed timelines following quality standards.
Leads and/or participates in the development and review of Policies, SOPs and other controlled documents for process improvement and operational efficiency.
Provide statistical and strategical input in regulatory documents and scientific articles.
Lead data generation team for podium presentations and payor discussions.
Plays a critical role in shaping team development and contributing to departmental strategy.
Stays abreast of and contributes to scientific advances in the field.
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:

PhD in Statistics, biostatistics or related fields or Masters with significant experience

Experience:

12+ years of pharmaceutical industry experience with a PhD, or 14+ years with an MS.
Hands-on experience working with CDISC standards and programming based on raw datasets, SDTM, and ADaM datasets.
8+ years of management experience

Other Qualifications/Skills:

Hands-on familiarity with common and advanced statistical methodology.
Strong knowledge of SAS programming concepts and techniques in the pharmaceutical; proficiency in tools such as SAS, EAST, and nQuery.
Knowledge/experience of global regulatory requirements in novel endpoints and rare diseases is a plus

Travel:

About the Company

4DMT is a clinical stage biopharma company inventing and developing innovative products to unlock the full potential of genetic medicine to treat large market and rare diseases. Our vector discovery platform Therapeutic Vector Evolution harnesses the power of directed evolution, a Nobel Prize-winning technology, with approximately one billion synthetic AAV capsid-derived sequences to invent customized and evolved vectors with improved therapeutic profiles compared to wild-type vectors. Our product design, development and man... Know more