AskBio Inc. दुर्लभ और आनुवंशिक रोगों के लिए जीन उपचार विकसित करने वाली क्लिनिकल-स्टेज स्वास्थ्य सेवा कंपनी है। इसका कार्य एडेनो-असोसिएटेड वायरस (AAV) तकनीक पर केंद्रित है, जिसमें स्वामित्वयुक्त कैप्सिड, प्रमोटर और Pro10™ तथा neDNA™ जैसे विनिर्माण प्लेटफ़ॉर्म शामिल हैं। Bayer AG की पूर्ण स्वामित्व वाली, लेकिन स्वतंत्र रूप से संचालित सहायक कंपनी के रूप में AskBio अनुसंधान, नैदानिक विकास, विनिर्माण और सहयोगात्मक विशेषज्ञता को एक साथ लाकर उपचारों को खोज के चरण से मानव अध्ययनों तक आगे बढ़ाती है। कंपनी शैक्षणिक और उद्योग साझेदारों के साथ भी काम करती है और रोगी-केंद्रित अनुसंधान का समर्थन करती है, जिसमें देर से शुरू होने वाले Pompe रोग के लिए AB-1009 जैसे नैदानिक कार्यक्रम शामिल हैं।
Senior Director, Biostatistics and Clinical Operations - Durham Hybrid
Lead biostatistical strategy for AskBio’s gene therapy clinical development programs, including trial design and regulatory planning. Manage statisticians and collaborate with cross-functional teams in a hybrid U.S. role.
विवरण
- Lead technical strategy and operational oversight for non-clinical, CMC, and clinical development programs, studies, and trials, from design through reporting
- Review clinical trial designs and reports prepared by other biostatisticians
- Direct statisticians, programmers, and data managers to deliver accurate work on schedule
- Counsel senior leaders and functional heads on biostatistical strategy and issues affecting the business
- Oversee CRO biostatistics activities, scopes of work, and relationships with external statistical consultants
- Allocate resources, establish priorities, and maintain compliance with applicable standards
- Partner on protocol development, including study design, endpoint definition, and power and sample size calculations
- Direct statistical analysis plans, data analyses, and clinical study report content
- Contribute to Data Monitoring Committee charters and meeting preparation
- Represent AskBio and the Biostatistics function 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 activities
- Provide statistical expertise for clinical development plans, protocols, investigator brochures, regulatory submissions and responses, publications, and presentations
- Create and explain solutions to statistical and data analysis challenges across clinical, regulatory, and commercial functions
- Help maintain departmental SOPs, standardization initiatives, and statistical training programs
- Stay current with statistical methods, drug development practices, and regulatory requirements
- Evaluate external study designs and clinical trial data as part of due diligence activities
- Contribute to business development efforts at conferences and industry events
- Support scientific and medical meetings, including investigator meetings, advisory boards, DMCs, SABs, and engagements with key opinion leaders
- Represent AskBio through presentations at industry conferences
- Contribute to vendor assessment, selection, and oversight
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
- Deep knowledge of experimental design, clinical trial design or CMC statistics, drug regulation, and statistical function management
- Extensive SAS and/or R experience
- Strong written and verbal communication abilities
- Experience selecting, contracting with, and managing CROs
- Proven leadership and interpersonal skills, with the ability to earn trust and credibility within and outside the organization
- Experience with adaptive and Bayesian study design simulation methods
- Experience working in rare disease and/or gene therapy programs
लाभ
- Opportunity for secondment to AskBio for a duration determined by Bayer and AskBio leadership, typically one to two years
- Equal Opportunity Employer
- Reasonable accommodation available for qualified individuals with a disability or disabled veteran