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Biostatistics Director
hace 1 mes
**Location: Home-based or at any of the company's offices throughout Europe that match your geographic location**
**Who we are?**:
Optimapharm is a leading, mid-sized, **full-service CRO working across Europe and North America** to deliver new therapies to improve and save patients’ lives. Optimapharm’s key priorities are our people and consistently exceeding our client’s expectations.
With **27 strategically located offices**, Optimapharm operates in 40+ countries, giving unrivaled access to Patients and Investigators in all countries in Europe and North America.
In-depth expertise and long-standing experience, combined with a flexible and collaborative approach, allow optimization of design and planning; through its strong track record of delivery excellence and committed and stable project teams, Optimapharm has secured a high level of repeat business over the years.
We are looking for a **Biostatistics Director **to join our** **team and support us in making a tangible difference to project sponsors and benefiting patients and their families all around the world.
❗ As a Biostatistics Director, you will be **collaborating closely with** the VP of Biostatistics and COO**, and you will be **responsible for** leading, training, and supervising the team, as well as being hands-on with the projects.**
**What do we offer?**:
- Working in a successful company that is growing and evolving every day
- Working with a highly experienced team of clinical research professionals
- International projects and professional growth
- Performance bonus
- Training opportunities
**Who are we looking for?**:
**Qualifications and** Experience**:
- MSc or higher degree in Biostatistics, Mathematics, or equivalent required
- Minimum of 10 years of clinical research experience is required
- Minimum of 2 years of management experience required, within CRO and/or Bio-Pharmaceutical Industry Biostatistics departments
- Excellent knowledge of GCP and ICH Guidelines
- Excellent knowledge of regulatory requirements in biostatistics
- Excellent knowledge of statistical methods and data management standards
- Product development experience and excellent understanding of pharmaceutical development processes
**Your **responsibilities**:
- Oversee the development and implementation of strategies (as agreed with the VP of Biostatistics and COO) for the Biostatistics Services department. This includes guiding, supporting, and managing department personnel and ensuring effective teamwork across various functions.
- Ensure high-quality results consistent with expectations and quality control procedures. Address training gaps in the department, oversee document management, and participate in developing and reviewing controlled documents.
- Identify and capitalize on new business opportunities within the life science industry. Contribute to proposal strategies, costing, and bid defenses. Stay informed about industry trends and participate in company strategy reviews.
- Manage the allocation and utilization of resources efficiently. Oversee the department's financial performance, including budgeting and ensuring projects are delivered within scope and budget.
- Ensure timely and quality delivery of client deliverables for assigned projects. Participate in the creation and review of key statistical documents and provide consultation and support in statistical methods and analyses.
- Demonstrate a comprehensive understanding of biostatistical methodologies and stay familiar with regulatory requirements in design, analysis and reporting of clinical trials.
**By joining our fast-growing and prosperous team, you will have an excellent opportunity for further personal growth and career development.
