Senior Biostatistician

AL Solutions are partnered with an exciting, small clinical stage Radiopharma organisation that have recently secured their series A funding and looking for a Senior/Principal Biostatistician to be their first in-house employee within the Biometrics team.

Our partner are entering a very exciting period with one of their Oncology studies moving into Phase 2, with a further study on track to enter Phase 1. With this upward tredjectory, this is a unique opportunity to join the team in the early stages of their development process, with excellent future prospects as they continue to build.

This is hybrid position, with one day required on-site in Oxford, with a requirement for the candidate to be based in the UK.

Responsibilities:

• Perform the role of the Lead Statistician
• Selection and management of Biometric vendors supporting studies
• Provide input into study design
• Produce Statistical Analysis plans
• Support data review in clinical studies (TFL's, CDISC, SDTM, ADaM and data submission packages including Pinnacle21, define.xml etc)
• Involvement to New Drug Application and Market Authorisation Application, contributing to review of clinical study reports

Experience Required:

• Extensive background working in Biostatistics, within a Pharmaceutical/Biotech environment
• Good understanding of SAS Programming and data management concepts and practices
• Previous experience working within Oncology
• Strong experience with clinical study design
• In depth knowledge and understanding of CDISC
• Vast knowledge of the drug development process
• Previous experience managing budgets and timelines

Please reach out to Jack Kavanagh for more information on this opportunity!