Director Biometrics

AL Solutions are partnered with an exciting, small clinical stage Radiopharma organisation that have recently secured funding and are looking for an AD / Director of Biometrics to join their innovative team.

Our partner has recently secured funding and are now in a position to make their first in-house hire into this new unit, performing oversight to external vendors whilst performing hands-on activities. We can consider experienced Biostatisticians that are looking to take the next step in their career.

This is a 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
• 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 in New Drug Application and Market Authorisation Application, contributing to the review of clinical study reports

Experience Required:

• Extensive background working in Biostatistics, preferably 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
• Understanding the process flow from start of database build activities to go-live.
• Previous experience managing budgets and timelines

#J-18808-Ljbffr