Sr/Pr Biostatistician

Updated: Yesterday Location: ESP-Remote (Madrid) Job ID: About Syneos Health Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for. Whether you join us in a Functional Service Provider partnership or a Full‑Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate to change lives. Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Diversity of thoughts, backgrounds, cultures, and perspectives creates a place where everyone feels like they belong. Job Responsibilities Provide support across all assigned statistical tasks during the lifecycle of the project, from protocol to Clinical Study Report (CSR). Prepare Statistical Analysis Plans (SAPs), including development of well‑presented mock‑up displays for tables, listings, and figures. Responsible for statistical aspects of the protocol, generation of randomization schedule, publications, and input to the clinical study report. Coordinate activities of biostatistics and statistical programming personnel to ensure timely completion of high‑quality work. Provide independent review of project work produced by other biostatisticians in the department. Review programming specifications for analysis datasets, tables, listings, and figures. Review SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met. Conduct verification and quality control of project deliverables, ensuring outputs meet expectations and align with SAP and specifications. Implement company objectives and develop alternative solutions to address business and operational challenges. Serve as biostatistics representative on project teams, interfacing with other departmental team representatives, preparing for internal meetings, contributing ideas, and demonstrating respect for opinions of others. Manage scheduling and time constraints across multiple projects, set goals based on priorities from management, and adapt to timeline or priority changes by reorganizing daily workload. Monitor progress on study activities against agreed milestones and ensure study timelines for project deliverables are met. Identify out‑of‑scope tasks and escalate to management. Provide statistical programming support as needed. Participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non‑voting biostatistician. Lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor. Follow applicable SOPs, work instructions, and relevant regulatory guidelines (e.g. ICH). Maintain well‑organized, complete, and up‑to‑date project documentation, verification/quality control documents and programs; ensuring inspection readiness. Display willingness to work with others and assist with projects and initiatives to meet the needs of the business. Support business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings. Co‑coach and mentor other Biostatistics staff. Perform other work‑related duties as assigned. Minimal travel may be required. Qualifications and Requirements Previous lead experience within Oncology is required. This position is open to Europe only. Strong experience in statistical analysis and programming within clinical research. Proficiency in SAS and statistical methodology. Excellent communication, teamwork, and project management skills. Ability to work independently and across multiple projects. Get to Know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA approved drugs, 95% of EMA authorized products, and more than 200 studies across 73,000 sites and 675,000+ trial patients. No matter what your role is, you’ll take initiative and challenge the status quo with us in a highly competitive and ever‑changing environment. Contact and Equal Opportunity Information Phone: Fax: Toll‑Free: Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender identity, sexual orientation, protected veteran status, disability, or any other legally protected status. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, please contact us at: . Website: #J-18808-Ljbffr