Associate Director / Head of Biostatistics - Top Pharma - UK / Belgium / Netherlands / France

Our client, a leading global pharma is looking for an expert biostatistician to join, their dynamic team, working on exciting projects in Rare disease. You will require Line Management experience, as well as regulatory interactions.

Purpose

• Provide statistical expertise and contributions for projects and protocols in support of Drug Development Programs
• Provide statistical expertise on regulatory submissions and ensure quality and appropriateness of submission deliverables
• Provide/oversee statistical support to planning, preparation, review, and interpretation of data for clinical trials (interventional, observational and registries studies)
• Ensure that data are analysed and evaluated with appropriate statistical methodologies
• Coordinate Statistical Input for all clinical and safety data systems at Chiesi and support preparing data and metadata packages for regulatory submission
• Coordinate operational activities of staff members

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
• Coordinate and manage the statistical deliverables required by eCTD submission
• 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
• Show initiative in keeping self at the "leading-edge" of the field
• 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
• Ensure proper collaboration within the Biometrics team and with the clinical/operational teams.
• Supervise and support the operational activities of statistical staff
• 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
• Contribute to definition of SODs, if needed
• 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
• Participate in the company recruitment program as needed
• Responsible to ensure compliance with Safety and Employment policies (e.g., Respect in the Workplace - Prevention of Violence and/or Harassment)
• Work as a member of a team to achieve all outcomes

Experience Required

• A significant experience in the field, as defined below, is required for the current role:
• (MANDATORY) At least 10 years of experience in the role of statistician in the clinical development of pharmaceutical products in pharmaceutical industries and/ or CROs (possibly including phase 4 and registry/observational studies)
• (HIGHLY VALUED) 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
• A clear experience and mastering of the following standards should also be demonstrated:
• ICH GCP as well as general knowledge of industry best practices and standards, such as CDISC (ADaM)

Education

• University Degree in Statistics, Mathematics or related disciplines

Languages

• English Fluent

Soft Skills

• Attention to details
• Communication skills
• Leadership and social influence
• Planning and organizational skills
• Strategic thinking

Demonstrated exceptional ability and performance.

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