Associate Director – Biometrics

Job title:

Associate Director – Biometrics

Company

Warman O’Brien

Job description

5127 Posted: 23/01/2025

• £Competitive
• -, United Kingdom
• Permanent

Associate Director Biostatistics – Innovative Biopharma- UK – Hybrid / RemoteWe have partnered with a renowned Biopharma, who are looking for an exceptional lead statistician to join their pioneering and innovative team, working on Oncology studiesDesirable Experience for this role:

• Fulfil the role of lead biostatistician on a clinical study as part of the project team.
• Selection and management of biometrics vendors supporting the company sponsored/ managed studies including costing, timelines, budget management and contracts
• Provide input and support into trial design and protocol
• Produce/ review statistical analysis plans
• Support the data review in clinical studies
• Contribute to New Drug application (NDA) / Market Authorisation Application (MAA) documentation, including review of clinical study reports
• Coordinate closely with other functions including Medical, Clinical Operations, Imaging, and Regulatory Affairs.

How will you be a success?
Ability to show demonstrated expertise in:

• Data management and statistical methods
• Planning and budgeting for data management & data analysis in complex clinical trials; including data handling in electronic data capture platforms
• Management of contract vendors in data management, programming, and statistical activities
• Regulatory submission/interaction including phase Ill trial management, NDA/MAA submission and support, regulatory interactions, data submission standards etc.
• In-depth understanding of CDISC Standards
• In-depth understanding of the drug development process, including experience with regulatory filings
• Good understanding of SAS programming concepts, good programming practices and techniques related to drug development
• Knowledge of Good Clinical Practice (GCP) regulations/requirements
• Oncology and diagnostic imaging experience

Qualifications:

• PhD or M.S in Biostatistics, Statistics, or a related scientific field
• Proficiency in SAS required.

What do you get in return?

• Working a friendly group with exciting pipeline
• Excellent opportunities to develop and grow.
• Home working flexibility
• Industry leading salary, annual bonus, & benefits
• Being part of a motivated and experienced team in an innovative and diverse working environment.

What to do next: If this opportunity is of interest, please apply now with your CV as the organisation are looking to welcome the new Statistician onboard as soon as possible.
Not what you are looking for? Please contact Aimee Weston on 07806 790645 for a confidential discussion about potential opportunities.

Expected salary

Location

United Kingdom

Job date

Fri, 14 Mar 2025 03:09:06 GMT

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