Senior Manager, Biostatistics – Rare Disease Biotech – East/Central Coast, USA
Global Life Science Hub is working with a stimulating Biotechnology company based on the East Coast, developing novel therapeutics for extremely rare diseases. In the last 2 years, they have accomplished 150% growth from 120 employees to 350.
Their extraordinary growth has come from accomplishing their first approval for the US, EU and the Middle East. With the successful launch and achieving $160 million in revenue, they can continue focusing on the additional 4 promising compounds in their pipeline.
Due to their continuous success, they are now searching for a new Senior Manager, Biostatistics which is a perfect step up for a Principal Statistician or a very experienced Senior Stat. The Senior Manager is a member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions and publications.
- Will be statistical study lead for a program in development; will also help with Stats plan and mock shells for in-house programming.
- Provide statistical input into Clinical Development Plans, Clinical Study Protocols, Clinical Study Reports, regulatory submission documents, and publications ensuring accurate deliverables
- Perform sample size calculations, develop statistical analysis plans and lead TLF development
- Perform statistical analyses and validate analysis results
- Provide statistical leadership for clinical development programs in phases 1-2.
- Collaborate in clinical program & study design, biomarker & clinical pharmacology strategy, methodology, data analysis & interpretation.
- Continually develop statistical skills and use novel statistical methodology when appropriate.
- Develop & advise other team members.
- Provide support to the statistical project lead for meetings with regulatory agencies such as the FDA
- Provide support to the statistical project lead in the review or writing of regulatory briefing documents, regulatory dossiers such as NDAs and MAAs, and responses to regulatory questions
- MS in Stats required; PhD is preferred (Bayesian stats) but not essential
- 6 years required in Pharma/CRO
- Must know how to use basic stats procedures in SAS.
- Should have experience in Phase II/III level studies
- Exposure to NDA is (datasets must be STDM, must have ADaM datasets, all modules for NDA. 2.73 summary of efficacy. 2.7 is summary of safety)
- Strong knowledge of eCRFs, DMPs, SAPs.
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