Asklepios BioPharmaceutical, Inc. (AskBio) este o companie de biotehnologie care dezvoltă terapii genice pentru boli genetice. Deținută integral de Bayer AG, compania se concentrează pe tehnologiile bazate pe virusuri adeno-asociate (AAV) și pe programe terapeutice pentru afecțiuni neuromusculare, ale sistemului nervos central, cardiovasculare și metabolice. Portofoliul său de dezvoltare include AB-1003 (LION-101), care a primit din partea FDA desemnările pentru boală pediatrică rară și medicament orfan pentru distrofia musculară a centurilor de tip 2I/R9. Activitatea AskBio reunește cercetarea, dezvoltarea clinică și medicina genetică pentru a avansa tratamente potențiale pentru pacienții cu tulburări ereditare grave.
Senior Director of Biostatistics, Clinical Operations — AskBio (Hybrid)
Lead biostatistics strategy and clinical operations for AskBio’s gene therapy development programs. Oversee trial design, regulatory support, statistical teams, and CRO partnerships.
Descriere
- Lead technical strategy and operational delivery for non-clinical, CMC, and clinical development programs, studies, and trials
- Review clinical trial designs and reports prepared by other biostatisticians
- Guide and manage statisticians, programmers, and data managers
- Advise senior leaders and functional stakeholders on biostatistics strategy and business-critical matters
- Direct CRO biostatistics activities, scopes of work, and external statistical consultant relationships
- Allocate resources, establish priorities, and uphold consistent standards
- Contribute to protocol development, study design, endpoint selection, and power and sample size evaluations
- Lead statistical analysis plans, data analyses, and clinical study report content
- Support Data Monitoring Committee charters and meeting preparation
- Represent AskBio in discussions with the FDA, EMA, and other health authorities
- Contribute to regulatory submissions and agency interactions, including IND and BLA filings and potential partnering requests
- Provide statistical expertise for development plans, protocols, investigator brochures, regulatory materials, publications, and presentations
- Resolve and communicate solutions to statistical and data analysis challenges
- Help develop departmental SOPs, standardization initiatives, and statistical training
- Stay current with statistical methods, drug development practices, and regulatory guidance
- Support due diligence, business development, scientific and medical meetings, vendor management, and industry conferences
Cerințe
- Ph.D. or M.S. in statistics or a related discipline
- At least 10 years of pharmaceutical experience in a pharmaceutical or biotechnology R&D setting
- Familiarity with cardiovascular, metabolic, kidney, CNS, and/or rare disease programs
- Prior experience preparing and submitting New Drug Applications to regulatory authorities
- Advanced knowledge of experimental design, clinical trial design or CMC statistics, drug regulation, and statistical function management
- Extensive experience using SAS and/or R
- Strong written and verbal communication skills
- Experience selecting, contracting with, and managing CROs
- Proven leadership and interpersonal ability to build credibility and trust within and outside the company
- Experience with adaptive and Bayesian study design simulation methods
- Experience in rare disease and/or gene therapy development
Beneficii
- AskBio is an equal opportunity employer
- Reasonable accommodation is available for qualified individuals with a disability or disabled veteran