Biostatistics Director
hace 4 semanas
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 dayWorking 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 requiredMinimum of 10 years of clinical research experience is requiredMinimum of 2 years of management experience required, within CRO and/or Bio-Pharmaceutical Industry Biostatistics departmentsExcellent knowledge of GCP and ICH GuidelinesExcellent knowledge of regulatory requirements in biostatisticsExcellent knowledge of statistical methods and data management standardsProduct development experience and excellent understanding of pharmaceutical development processesOversee 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. If you would be interested in joining the Optimapharm team, please send your CV in English and note that only shortlisted candidates who meet the requirements will be contacted for the further selection process.
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