|Job title :||Senior Director Biometry - Biotech|
|Job type :||Permanent|
|Contact name :||Yanick Millet|
|Contact number :||+44 (0) 207 255 6610|
|Contact email :||email@example.com|
In this role, the Senior Director will be responsible for driving the company's Biometrics activities for all studies including supervision of biostatistics, programming, and Data Management activities.
Job Responsibilities include (but are not limited to):
- Defining and delivering the vision and goals for the Biometrics department
- Ensuring statistical leadership within the Biometrics department.
- Leading statistical strategy as well as clinical development plans and regulatory submissions.
- Supporting the clinical study team on the collection, interpretation and reporting of clinical data.
- Providing support / coordinate statistical methodology and technical guidance.
- Managing department resource allocation to support all clinical trial projects.
- Supervising the Biometrics team which includes recruitment if needed, team members development, target setting, performance management and mentoring.
- Networking with partners, Building and maintaining effective strategic working relationships such as industry, academic, professional and other organizations.
- Responsible for GCP compliance and Standard Operating Procedures (SOPs).
- Serve as a statistical consultant for other members of the department and staff members from other departments within the company.
Required Skills and Qualification:
- PhD in biostatistics or related field and at least 12 years relevant experience.
- Master's degree in biostatistics or related field and at least 15 years relevant experience.
- 15 years' experience in biostatistics within the Pharma/Biotech/CRO industry.
- Project Management Required.
- International experience preferred.
- At least 15 years' experience in clinical drug development & Statistical expertise with emphasis in late clinical stage.
- Strong experience of regulatory interactions and submissions in Europe and US
- Strong interest in driving innovation and capabilities in supervising scientific/technical work.
- In depth knowledge of applicable clinical research regulatory requirements and international statistical guidelines (i.e. ICH GCP).
- Strong skills in developing people and teams.
- Excellent communication skills