Director of Biostatistics
About The Position
Eupraxia is a clinical-stage biotechnology company focused on developing locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. DiffuSphere™, a proprietary, polymer-based micro-sphere technology, is designed to facilitate targeted drug delivery of both existing and novel drugs. The technology is designed to support an extended duration of effect and delivery of drugs in a hyper-localized fashion, targeting only the tissues that physicians want to treat. We believe the potential for fewer adverse events may be achieved through the precision targeting and the stable and flat delivery of the active ingredient when using the DiffuSphere™ technology, versus the peaks and troughs seen with more traditional drug delivery methods. The precision of Eupraxia's DiffuSphere™ technology platform has the potential to augment and transform existing FDA-approved drugs to improve their safety, tolerability, efficacy and duration of effect. The potential uses in therapeutic areas extend beyond pain and inflammatory gastrointestinal disease, where Eupraxia is currently developing advanced treatments, to applications in oncology, infectious disease and other critical disease areas. Eupraxia's EP-104GI is currently in a Phase 1b/2 trial (RESOLVE) for the treatment of eosinophilic esophagitis (EoE). EP-104GI is administered as an injection into the esophageal wall, providing local delivery of drug. This is a unique treatment approach for EoE. Eupraxia also recently completed a Phase 2b clinical trial (SPRINGBOARD) of EP-104IAR for the treatment of pain due to knee osteoarthritis. The SPRINGBOARD trial successfully met its primary endpoint and three of the four secondary endpoints. In addition, Eupraxia is developing a pipeline of later and earlier-stage long-acting formulations. Potential pipeline indications include candidates for other inflammatory joint indications and oncology, each designed to improve on the activity and tolerability of currently approved drugs. For further details about Eupraxia, please visit the Company's website at: www.eupraxiapharma.com. The Director of Biostatistics provides strategic and operational leadership for biostatistical activities within and across clinical development programs. This role is responsible for ensuring the integrity, quality, and rigor of statistical analyses and methodologies applied to clinical studies. They will serve as the primary statistical representative in cross-functional teams and lead biometrics related activities for regulatory submissions (IND, NDA/BLA, MAA). This role may supervise junior statisticians or function as a senior individual contributor.
Requirements
- Master’s degree or PhD in biostatistics or statistics
- 15+ years of biotech/pharma experience as a biostatistician
- Demonstrated experience supporting pivotal and registrational clinical trials
- Strong CRO and vendor oversight experience
- Track record of delivering high quality statistical related deliverables
- NDA/BLA experience
- Excellent knowledge of SAS
- Experience with sample size calculation software such as nQuery, EAST, etc.
Nice To Haves
- Knowledge of R a plus
Responsibilities
- Leads and oversee biostatistical strategy for one or more clinical development programs.
- Serves as a key contributor to study design and protocol development.
- Develops statistical analysis plans (SAPs) and table, listing, and figure (TLFs) shells.
- Ensures that clinical trial designs and proposed analysis methods are robust and follow regulatory guidelines (FDA, EMA, etc.)
- Oversees the production of TLFs for interim and final analyses and ensures that it is of high quality and delivered on time.
- Provides hands-on oversight of CROs and external statistical reporting groups to ensure quality standards and timelines are met for statistics related deliverables
- Manages statistical vendors for independent data monitoring committees
- May supervise junior biostatisticians
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What This Job Offers
Job Type
Full-time
Career Level
Director
