- Company: AskBio
- Location: US
- Full Time
- US
- Apply on company site
AskBio at a glance
askbio.comSEC filings mentioning "AskBio": 135 — search EDGAR
AskBio, a Bayer AG subsidiary, is recruiting a Director of Biostatistics to lead clinical operations strategy across our gene therapy portfolio in the United States. This full-time position offers the opportunity to shape statistical approaches for innovative programs targeting serious neurological, cardiac, and metabolic conditions.
About the Role
In this senior leadership position, you'll oversee the biostatistics function for our clinical portfolio, ensuring rigorous study design, regulatory compliance, and data integrity across all development programs. You'll serve as the statistical authority guiding trial strategy, working closely with clinical development, regulatory affairs, and research teams to advance breakthrough therapies from design through regulatory approval.
What You'll Do
- Design statistical strategies, protocols, and analysis plans for clinical trials across therapeutic areas
- Ensure compliance with FDA regulations, ICH guidelines, and international regulatory requirements
- Lead, mentor, and develop a high-performing biostatistics team
- Oversee data quality, database management, and biostatistical analysis
- Support preparation and review of regulatory submissions and agency communications
- Advance statistical methodologies tailored to gene therapy development
- Collaborate with cross-functional teams to drive operational excellence
What We're Looking For
- Graduate degree (MS or PhD) in Biostatistics, Statistics, or a closely related field
- Extensive experience in clinical biostatistics within pharmaceutical or biotech environments
- Deep expertise in regulatory affairs, FDA submissions, and compliance frameworks
- Demonstrated leadership managing and mentoring statistical teams
- Excellent written and verbal communication for cross-functional stakeholder engagement
- Experience in gene therapy, rare disease, or specialty therapeutic development is valued
About AskBio
AskBio is an independently operated gene therapy company within the Bayer group, committed to discovering and developing transformative medicines. Our clinical portfolio spans multiple serious disease indications, and we're advancing programs designed to offer hope to patients with limited therapeutic alternatives.
How to Apply
To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.
To apply for this job please visit www.adzuna.com.
Explore AskBio online
What people say about AskBio
- Show HN: I made an app that can accelerate cures and nobody fucking cares
- The Alpha Myth: How captive wolves led us astray
- YC W15 emails are out
- Building an API in 60 seconds, without any server setup
Recent news
- AskBio's Viralgen to Supply Commercial-Scale Drug Product for REGENERATE-PD Investigational Gene Therapy Phase II Trial for Parkinson’s Disease - Bayer
- RTP’s AskBio wants to make $4 billion price tag look like a bargain - Raleigh News & Observer
- AskBio Doses First Patient in Phase 1/2 Gene Therapy Trial for Late-Onset Pompe Disease - BioPharm International
- Patients Treated With AskBio’s Limb-Girdle Muscular Dystrophy Gene Therapy AB-1003 Free of Serious Adverse Events at Up to 52 Weeks - CGTLive®
- AskBio Publishes 12-month Data from Phase 1 Gene Therapy Trial in Participants with Congestive Heart Failure - dicardiology.com
Latest from AskBio
- First Participant Dosed in AskBio Phase 1/Phase 2 Gene Therapy Trial of AB-1009 for Late-Onset Pompe Disease (LOPD)
- AskBio Announces 6 Presentations at American Society of Gene and Cell Therapy (ASGCT) 29th Annual Meeting
- AskBio’s Viralgen to Supply Commercial-Scale Drug Product for REGENERATE-PD Investigational Gene Therapy Phase II Trial for Parkinson’s Disease
Aggregated from public discussions and news; opinions are the authors’ own.
Working in US
The United States of America (USA), also known as the United States (U.S.) or America, is a country primarily located in North America. It is a federal republic consisting of 50 states and a federal capital district, Washington, D.C. The 48 contiguous states border Canada to the north and Mexico to the south, with the semi-exclave of Alaska in the northwest and the archipelago of Hawaii in the Pacific Ocean. The United States also asserts sovereignty over five major island territories and various uninhabited islands in Oceania and the Caribbean. It is a megadiverse country, with the world's th
🇺🇸 Relocation safety for US: Exercise Normal Caution — via Warnely, CC BY 4.0
National unemployment rate in US: 4.2% — via World Bank
GDP per capita in US: $90,027 — via World Bank
Consumer price inflation in US: 2.9% (annual) — via World Bank
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