Asklepios BioPharmaceutical, Inc. (AskBio) एक जैव प्रौद्योगिकी कंपनी है जो आनुवंशिक रोगों के लिए जीन थेरेपी विकसित करती है। Bayer AG की पूर्ण स्वामित्व वाली इस कंपनी का ध्यान एडेनो-असोसिएटेड वायरस (AAV) तकनीकों और न्यूरोमस्कुलर, केंद्रीय तंत्रिका तंत्र, हृदय-संबंधी तथा चयापचय संबंधी रोगों के उपचार कार्यक्रमों पर है। इसकी पाइपलाइन में AB-1003 (LION-101) शामिल है, जिसे लिम्ब-गर्डल मस्कुलर डिस्ट्रॉफी प्रकार 2I/R9 के लिए FDA से दुर्लभ बाल रोग और अनाथ-दवा पदनाम प्राप्त हुए हैं। AskBio का कार्य अनुसंधान, नैदानिक विकास और आनुवंशिक चिकित्सा को एक साथ लाकर गंभीर वंशानुगत रोगों से पीड़ित लोगों के लिए संभावित उपचारों को आगे बढ़ाता है।
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.
विवरण
- 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
आवश्यकताएँ
- 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
लाभ
- AskBio is an equal opportunity employer
- Reasonable accommodation is available for qualified individuals with a disability or disabled veteran