Director of Biometrics

AL Solutions
Nottingham
1 month ago
Applications closed

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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 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, preferrably 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


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


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