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
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Contact Detail:
AL Solutions Recruiting Team