Director, Biostatistics and Data Management
This opportunity is for a drug development consultancy with significant experience in partnering with biotech and pharmaceutical companies across Europe, US and Asia to advance their projects. Offering multi-disciplinary consulting and operational solutions spanning all areas of regulatory affairs, clinical research, clinical trial supply, CMC development, pharmacovigilance, and the advancement of pharmaceutical and biotech products and medical devices. Offices spanning across Europe, with offices in Denmark, Sweden, Germany, France, Italy and Netherlands.
This opportunity is for a Director Data Management and Biostatistics into a dynamic and skilled team within Clinical Operations Solutions based in Munich, Germany. The correct person will be skilled and experienced in Data Scientist and be highly motivated professional and talented team leader with a positive, proactive, flexible and self-confident personality.
The position as Director Data Management and Biostatistics :
The Director Data Management and Biostatistics is the operational leader of the Data Management and Biostatistics division in Europe. The successful candidate will be accountable for defining the department business strategy, to guarantee highest quality deliverables.
The main responsibilities of the successful candidate will be:
1) Business strategy and delivery:
- Evaluate and implement suitable and cost effective systems and technical solutions that support our business needs.
- Develop and drive the strategy and objectives of the Data Management & Biostatistics department.
- Responsible for the group's budget, scheduling, and standards
- Leading role in the development and continuous update of processes, procedures and harmonization's.
- Leading continuous operational improvement, optimization workflows and quality initiatives.
- Ensuring the highest quality of deliverables according to the best standards and client expectations.
2) Functional leadership:
- Ensure constant professional development of the departmental services and resources.
- Align with actual and future business demand and requirements.
- Constant development of department training plans including individual development of employees in your team
- Led the team and by demonstrating and promoting business awareness within the department.
- Support of program and project level operational activities as much as possible.
3) Business development and sales:
- Aiding the Senior Director COS and corporate business development in development and execution of business development and sales targets.
- Contribution to the development of client proposals and in bidding defense meetings.
- Contribution to DM+Biostats related sales initiatives/ activities
- Support the generation of repeat business by ensuring compliance with delivery on existing Contracts.
Director Data Management and Biostatistics should possess the following qualifications and skill set;
- Proven knowledge of duties and deliverables within the biostatistics and data management fields.
- Awareness of recent state of the art statistical and/or data management processes & processes.
- Knowledge of GCP and other relevant regulatory guidelines and conditions.
- Great knowledge of medical, data management and biostatistical terminology clinical trial procedures and drug development.
- Solid leadership and organizational skills including ability to inspire employees and teams.
- in the life sciences division and at least 5-7 years' involvement in the pharmaceutical / BioTech / CRO industry.
- Excellent verbal and written communication skills.
- Good written and verbal skills
- Good collaboration skills.
- Like working in an international environment.