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Asklepios BioPharmaceutical, Inc. (AskBio)
Asklepios BioPharmaceutical, Inc. (AskBio)
501 – 1,000 Employees
BiotechnologyConsultingHealthcare
Asklepios BioPharmaceutical, Inc. (AskBio) is a biotechnology company developing gene therapies for genetic diseases. Wholly owned by Bayer AG, the company focuses on adeno-associated virus (AAV) technologies and therapeutic programs spanning neuromuscular, central nervous system, cardiovascular, and metabolic conditions. Its pipeline includes AB-1003 (LION-101), which has received FDA rare pediatric disease and orphan-drug designations for limb-girdle muscular dystrophy type 2I/R9. AskBio’s work brings together research, clinical development, and genetic medicine to advance potential treatments for patients with serious inherited disorders.
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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.

USUnited StatesNCNorth CarolinaOHOhioPAPennsylvaniaHybridFull-timeSeniorEnglish RequiredClinical Operations

Description

  • 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

Requirements

  • 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

Benefits

  • AskBio is an equal opportunity employer
  • Reasonable accommodation is available for qualified individuals with a disability or disabled veteran

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