Associate Director, Biostatistics – United States (Remote) – $190,000 – $220,000
Global Life Science Hub are partnered with a niche clinical-stage oncology biotech focused on the discovery of novel therapies for Solid Tumours. With 4 assets in phases II/III and an extensive pipeline of pre-clinical discovery makes this a truly exciting up and coming oncology player.
Following a successful phase II reading for their lead product, they’re now searching for an Associate Director of Biostatistics to strengthen their tight-knit team of 6 in their mission to shut down one of the most mutated cancers.
Reporting directly to the Vice President of Biometrics, the appointed candidate will be responsible for providing statistical leadership and strategic partnership to the development of the clinical development plans as well as have a “hands-on” approach across their extended molecules.
- Work with project team members on developing clinical protocol
- Review CRFs, CRF edit checks and CRF completion guidelines
- CRO / Vendor Oversight: Review CRO/vendor proposal and budget. Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies.
- Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review
- Provide statistical leadership in the development and implementation of data collection instruments to ensure they are designed to capture protocol-specified scientific information and study databases are implemented adequately
- Author statistical analysis plan, TLF shells and Table of contents for outputs to be generated
- MSc in Statistics at minimum, PhD in mathematics, Statistics or Biostatistics is highly preferred
- At least 8 year experience as a Biostatistician within the pharmaceutical industry
- Experience in Oncology and Study Phases I-III
- Experience with managing CROs and Vendors
- Strong SDTM and ADaM experience is required
- Proficient in SAS Programming, R experience is a bonus
- Ability to effectively represent Biostatistics and Clinical Data Management
The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com