Joshua Leggett has partnered with a niche, blue-ocean, Rare/Orphan Disease biotech with>120 employees focused on developing Rare, critical, lifesaving therapies. They have recently achieved an additional €90million to establish their lead product to commercialisation in early 2023.
Due to this astounding success, they’re now searching for their first in-house Senior Director, Statistics who can work closely with external vendors and aim to bring the Stats activities in-house and manage the new team of Programmers & Data Managers. This is a remote opportunity anywhere in Europe with the opportunity to build up a brand-new function from the ground up.
- Provides statistical support as Biostatistics project lead for one or more compounds, including input into design and analysis of clinical trials, vendor oversight, and submission activities. It is anticipated that this person will provide support for one or more indications for compounds under study.
- Build the entire biometry and statistics function from ground up
- Effectively contributes to the formulation of clinical development strategies as regards optimal development program and study design
- Participates in the selection, direction, and supervision/management of CRO/ contract staff for performance of outsourced operational activities, including oversight of statistical programming
- Participation in clinical development/product management teams in support of organizational objectives
- Participation in meetings with regulatory agencies such as the FDA
- Monitoring and evaluation of relevant performance metrics
- Support products including clinical study protocols, statistical analysis plans, data management plans, regulatory briefing documents, regulatory dossiers such as NDAs and MAAs, responses to regulatory questions, scientific abstracts, and manuscripts
EXPERIENCE & QUALIFICATIONS:
- MS or PhD in Biostatistics with at least 5 years’ experience in the pharmaceutical industry, with relevant experience in the design, analysis and interpretation of clinical trials and with sufficient SAS programming
- Proven expertise with the disciplines, practices and procedures that pertain to biostatistics, programming, and understanding of clinical data management processes
- Demonstrated knowledge of the clinical development process and of relevant regulatory guidelines and requirements
- Small company ambition/mindset
AL Solutions are a niche Life Science recruitment consultancy. We place professionals across the UK/EU 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.alsolutions.co.uk or reach out to us via: