Head of Biostatistics
We are a gene therapy company changing lives with every genetic advancement.
Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that cure genetic diseases has never wavered.
As the only end-to-end gene therapy company in the industry, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.
We became a wholly owned, independently operated subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy Platform. Our global headquarters are in Research Triangle Park, North Carolina, a thriving biotechnology hub, and we maintain additional research and development operations in Scotland and France and gene therapy manufacturing in Spain.
We have an opportunity for the Head of Biostatistics to join the AskBio team in our Research Triangle Park (Durham), NC and be part of our continued success!
The Head of Biostatistics will provide strategic and operational leadership to AskBio’s biostatistics function and, with the right leadership experience and qualities, also the broad data sciences functions (e.g. data management, statistical programming). The incumbent will play a key role in the strategic planning for all clinical programs as well as pipeline growth at AskBio. The seniority/title will be determined based on the experience of the incumbent.
Responsibilities & Accountabilities
- Provide strategic and operational leadership to AskBio’s biostatistics function and also the broad data sciences functions
- Build and lead a team of biostatisticians and biostatistical consultants and mentor talents
- Partner with Therapeutic Sector Leader, Clinical Development, Regulatory Affairs and other functions to determine the overall clinical and regulatory strategy and plans for each product
- Responsible for the statistical aspects of clinical trials, including trial design implementation, data analysis, and reporting
- Work closely with clinicians, data managers, and statistical programmers in strategizing, planning, and analyzing clinical trials
- Partner with Therapeutic Sector Leads, Clinical Development, and other functions to develop core messages based on sound data science
- Author or review statistical analysis plans
- Partner with the Therapeutic Sector Leader and Clinical Development to brainstorm and formulate core messages and ensure consistent reflection of the data-driven conclusions of clinical trial results
- Partner with the Therapeutic Sector Leader and Clinical Development to prepare clinical documents and regulatory dossier and interact with regulatory agencies
- Serve as a matter of subject expert in data sciences
- Provide biostatistical guidance to preclinical study design, execution, data analysis, and reporting.
- Ph.D. in Statistics, Applied Statistics, or Biostatistics required
- A minimum of 10+ years of experience in designing and reporting clinical trials in all phases required
- Strong track record and demonstrated excellence in IND/NDA/BLA submissions and approvals
- Must have extensive experience in applying statistical knowledge and methodology (e.g. adaptive designs and Bayesian design and analysis) to scientific and clinical problems, hypothesis, and objectives
- Must be familiar with computational simulation, analysis of biomarkers, analysis of clinical imaging results, SAS programming, and other relevant software applications
- Excellent leadership and communication skills with an open style and collaborative spirit in interactions with colleagues, CROs, and external experts and collaborators.
- In-Depth understanding of regulatory guidance and guidelines, as well as general knowledge of the biopharmaceuticals industry best practices and standards
- Expert knowledge and extensive experience in regulatory agency interactions and submission strategies
- Hands-on experience and demonstrated expertise in global clinical development of gene and cell therapy and/or one of the therapeutic areas, including CV, CNS, and rare diseases, preferred.
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