Senior Manager Biostatistics - North Carolina
- Experience Level
AL Solutions are partnering with a very exciting, small clinical stage biotechnology organisation that specialise within Rare Diseases who are looking for a Manager of Biostatistics to be responsible for the planning and delivery of statistical activities of the organisations sponsored studies.
My client has an exceptional clinical pipeline with several studies in early development and a further product on course to be released into the market within the next 12 months. As a result of this, they are looking to expand extensively over the next 12-18 months and have recently started building a brand new in house statistics and programming team.
My client is located in Durham, North Carolina and can offer part remote flexibility (2/3 days per week), an excellent salary package and flexible start dates.
- Serve as the Biostatistics project lead for one or more compounds, including input to the drug development and regulatory strategy.
- Provide statistical support as the biostatistics lead, including input into design and analysis of clinical trials
- Effectively contribute to the formulation of clinical development strategies as regards optimal development program and study design
- Participation in clinical development/product management teams in support of organizational objectives
- Participation in meetings with regulatory agencies such as the FDA
- Participate in the selection, direction, and supervision/management of CRO/ contract staff for performance of outsourced operational activities
- Degree in biostatistics or related field
- Strong experience in design and analysis of Phase II/III clinical trials
- Previous experience with SAS
- Experience with regulatory submissions
- Strong leadership skills
- Proven expertise with the disciplines, practices and procedures that pertain to biostatistics, programming, and understanding of clinical data management processes
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.