Head of Statistics

Project Lead Statistician - Remote (France / Belgium / Netherlands / UK)

Job Overview: Who are they?

An award winning Global Pharma are currently searching for an experienced Statistician to join their successful Global Clinical Development, Statistics and Data Management team.

What’s in it for you?

• Salary up to €90,000
• Collaborative and inspirational working environment / atmosphere
• Ongoing training/development and career progression opportunities
• Excellent employment package and work/life balance

What you will be doing

You will be providing statistical expertise and contributions for projects and protocols in support of Drug Development Programs, as well as providing statistical expertise on regulatory submissions to ensure quality and appropriateness of submission deliverables.

As well as this, you will oversee statistical support to the planning, preparation, review, and interpretation of data for clinical trials (interventional, observational and registries studies) and coordinate operational activities of staff members (line management - 8 direct reports).

Main responsibilities:

• Ensure proper resourcing for all project requiring statistical input
• Work with the other functions in assessing and leveraging the need for statistical input.
• Provide statistical support for study design, sample size calculation, patient randomization, statistical methods and analyses, analysis, and interpretation of data, reporting of results
• Perform or supervise statistical activities for clinical trials
• Interact with CRO’s or other external vendors
• Demonstrate ability to make sound decisions on complex issues related to daily activities and refers contentious issues with recommendations to the next level
• Address any queries on statistical topics from regulatory agencies
• Participate in regulatory audits/inspections as required. Attend meetings with regulatory agencies to support drug registration
• Plan, review and conduct high quality statistical analyses, post-hoc analyses, exploratory analyses, or analyses requested by regulatory agencies interacting with SAS programmers, as needed
• Share relevant knowledge and experiences with the colleagues in internal meetings and provide instructions to more junior statisticians
• Participate and present, where appropriate, in educational activities
• Demonstrate leadership in creation and promotion of an environment of teamwork, clearly communicating the priorities and expectations
• Perform all work in accordance with established regulatory requirements ensuring compliance with GCP, GCDMP and CFR 21.11 guidelines, maintaining an in-depth knowledge of these documents

What can you bring to the table?

• At least 10 years of experience in the role of statistician in the clinical development of pharmaceutical products in pharmaceutical industries and/ or CRO's (possibly including phase 4 and registry/observational studies)
• Experience in clinical trials for rare diseases and of study design and statistical analysis approaches typically used in small population trials
• Experience in interactions with Regulatory Agencies, researchers, health care
• ICH GCP as well as general knowledge of industry best practices and standards, such as CDISC (ADaM)

What is the next step

Interested? Drop me a message or send your CV to aimee@warmanobrien.com receive more details surrounding this role and discuss this further!