Head of Biostatistics - Belgium
For a fast growing biopharmaceutical company in Belgium, we are currently in need of a ‘Head of Biostatistics’.
Our client is creating and developing a pipeline of antibody therapeutics, specialised in Oncology and Auto-Immune diseases.
They are currently in a Clinical stage and moving forward rapidly, which makes it a promising Biotech company.
We are looking for a Head of Biostatistics who will be responsible for the development and management of the biostatistics department, to provide statistical leadership in designs, analysis and result interpretation of clinical studies.
Next to this, you will be of strong influence int he decision making for Clinical Research and Development programs and be responsible for Line Management activities.
You will collaborate closely with the Leaders and Directors in the other departments like: Clinical Science, Clinical Operations, Pharmacovigilance, Regulatory and Project Management, and represent Bio-statistics to interact with external collaborators.
You responsibilities will consist of (but will not be limited to):
- Provide leadership and long-term vision to the Bio-statistics group
- Collaborate with the Head of Data Management, Clinical Operations, Medical Operations and all other, in order to contribute to the department strategic direction and company strategies
- Provide statistical direction and technical oversight for complex projects requiring statistical input as a Subject Matter Expert (SME) in statistics area.
- Clarify project deliverable’s and timelines for statistical analysis and reporting.
- Recruit, train, guide career growth, and provide development opportunities for biostatisticians.
- Support the presentation and publication of clinical trial results and contribution to advanced statistical topics.
- Lead the statistical research in clinical trial area
- Represent the company in all communications, conference calls, and face-to-face meetings with regulatory agencies
- Ph.D. in Biostatistics, Statistics or related field
- 10+ years of experience or MS with 12+ years of experience in the pharmaceutical industry
- Excellent knowledge of FDA and EMEA statistical guidelines.
- Submission experience including NDAs/MAAs
- Solid understanding of mathematical and statistical principles
- Excellent judgment and problem-solving skills in complex situations
- Excellent negotiation and interpersonal skills
- Ability to drive change and influence decision making
- Ability to reach out and collaborate with external expertise
- Ability to coach and provide feedback
- Ability to develop in-depth therapeutic area knowledge of the disease and treatments, and apply the knowledge to clinical development programs
Senior Associate Biotechnology