Sr/Pr Biostatistician - Immunology & Inflammation Job at Syneos Health, Inc. in

Overview Updated: October 21, 2025 Location: DEU-Remote Job ID: 25102409 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 places the customer and the patient at the center of everything we do, and we continually seek ways to simplify and streamline our work to better serve our customers and patients. 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 dedicated to changing lives. Discover what our 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE 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 unites us globally, and we are dedicated to taking care of our people. We continuously build the company we want to work for and that our customers want to work with. We believe diversity of thoughts, backgrounds, cultures, and perspectives creates a sense of belonging for everyone. Job Responsibilities Study lead 1-2 protocol (late phase, phase 2-3) For phase 3, may support another main statistic IRT, eCRF, DMC setup Study risk management plan (SRMP) Prepare SAP, tables, listings, and figures (tfls, STS) Review specifications STS (statistical surveillance), reviewing blinded data, 2-3 STS meetings during study life Recruiting the right patients; assess data quality and statistical assumptions Handling intercurrent events; SAS or R; may partially program the efficacy Provide support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborate with the sponsor, if required. May be responsible for the statistical aspects of the protocol, generation of randomization schedules, publications, and input to the clinical study report. Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high-quality work. Provides independent review of project work produced by other biostatisticians in the department. Creates or reviews programming specifications for analysis datasets, tables, listings, and figures. Reviews SAS annotated CRFs, database design, and other study documentation to ensure protocol criteria are met and all data is captured to support a high-quality database and planned analysis. Conducts and participates in verification and quality control of project deliverables, ensuring output meets expectations and aligns with SAP and specifications. Implements company objectives and creates alternative solutions to address business and operational challenges. Serves as biostatistics representative on project teams, including preparing for internal meetings, contributing ideas, and respecting diverse opinions. Manages scheduling and time constraints across multiple projects, sets goals based on management priorities, and communicates any difficulties with timelines to biostatistics management. Monitors progress on study activities against milestones and ensures study timelines for deliverables are met. Identifies out-of-scope tasks and escalates as needed. Provides statistical programming support as needed. May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician. May lead projects involving integrated analyses, attend regulatory agency meetings, or respond to questions to support statistical analysis results of clinical trials on behalf of the sponsor. Follows applicable SOPs, work instructions, and relevant regulatory guidelines (e.g. ICH). Maintains organized, complete, and up-to-date project documentation and verification/quality control documents and programs; ensuring inspection readiness. Displays willingness to work with others and assists with projects and initiatives as necessary to meet business needs. Supports business development activities by contributing to proposals, budgets, and sponsor bid defense meetings. Coaches and mentors other Biostatistics staff. Performs other work-related duties as assigned. Minimal travel may be required. 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 over 200 studies across 73,000 sites and 675,000+ trial patients. No matter your role, you’ll take initiative and challenge the status quo in a highly competitive environment. Learn more about Syneos Health. Tasks, duties, and responsibilities listed are not exhaustive. The Company may assign additional tasks at its discretion. Equivalent experience, skills, and/or education will be considered. This description is intended to comply with applicable laws and regulations, including the EU Equality Directive. The Company is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations when appropriate to perform the essential functions of the job. At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. We also encourage joining our Talent Network to stay connected to additional career opportunities. Discover what our 29,000 employees already know: work here matters everywhere. We work hard and smart to bring therapies to patients who need them. A career with Syneos Health means your everyday work improves patients’ lives globally. Syneos Health® (Nasdaq: SYNH) is a leading integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. We support a diverse, equitable and inclusive culture. Phone: 919 876 9300 Fax: 919 876 9360 Toll-Free: 866 462 7373 Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status. If you require reasonable accommodations to complete any part of our application process, please contact us at: Email: jobs@syneoshealth.com #J-18808-Ljbffr In Summary: Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success . We are committed to our Total Self culture – where you can authentically be yourself . The company has 29,000 employees across 110 countries . En Español: Resumen Actualizado: 21 de octubre de 2025 Ubicación: DEU-Remote Job ID: 25102409 Syneos Health® es una organización líder en soluciones biofarmacéuticas totalmente integradas construida para acelerar el éxito del cliente. Traducimos experiencias clínicas, médicas y comerciales únicas a resultados para abordar las realidades modernas del mercado. Nuestro modelo de Desarrollo Clínico coloca al cliente y al paciente en el centro de todo lo que hacemos, y buscamos continuamente formas de simplificar y agilizar nuestro trabajo para servir mejor a nuestros clientes y pacientes. Ya sea un socio proveedor de servicios funcionales o un entorno de servicio completo, colaborarás con apasionados solucionadores de problemas, innovando como equipo para ayudarles a alcanzar sus objetivos. Estamos dedicados e impulsados a acelera la entrega de terapias porque estamos apoyando nuestras vidas profesionales. Creemos que la diversidad de pensamientos, antecedentes, culturas y perspectivas crea un sentido de pertenencia para todos. Estudios sobre responsabilidades laborales lideran el protocolo 1-2 (fase final, fase 2-3) Para la fase 3, puede apoyar otra estadística principal IRT, eCRF, DMC configuración Plan de gestión del riesgo de estudio (SRMP) Preparar SAP, tablas, listas y cifras (tfls, STS) Revisar especificaciones STS (supervisión estadística), revisar datos ciegos, 2-3 reuniones STS durante la vida del estudio Reclutar pacientes adecuados; evaluar la calidad de los datos y las suposiciones estadísticas Manejar eventos intercurrentes; SAS o R; pueden programar parcialmente la eficacia Proporcionar soporte a todas las tareas estatísticas asignadas durante la duración del proyecto, desde protocolos patrocinadores hasta preparando planes de análisis estadístico (PSS), proporcionar informes de trabajo bien desarrollados, incluidos biciclos y otros aspectos relacionados con la generación de información clínica, así como elaborar cuentas y otras funciones específicas en el programación de estudios, crear cuadros de evaluación de tiempo, etc. SAS revisa los CRF anotados, el diseño de la base de datos y otra documentación del estudio para garantizar que se cumplan los criterios del protocolo y todos los datos son capturados para apoyar una base de información de alta calidad y un análisis planificado. Conducirá y participará en la verificación y control de calidad de las entregas del proyecto, asegurando que el resultado cumpla con las expectativas y se alinee con SAP y especificaciones. Implementará objetivos de la empresa y creará soluciones alternativas para abordar desafíos empresariales y operativos. Sirve como representante de biostatisticas en los equipos de proyectos, incluida la preparación de reuniones internas, aportando ideas y respetando diversas opiniones. Geren limitaciones de horario y tiempo a través de múltiples proyectos, establecen metas basadas en prioridades de gestión y comunican cualquier dificultad con calendarios a la administración de estadísticas biológicas. Monitorea el progreso de las actividades estudiosas contra hitos históricos y garantiza resultados cronológicos de entrega. Mantenemos la documentación del proyecto organizada, completa y actualizada, así como los documentos de verificación/control de calidad y programas; aseguramos la preparación para las inspecciones. Demuestra voluntad de trabajar con otros y ayuda en proyectos e iniciativas según sea necesario para satisfacer las necesidades empresariales. Apoya las actividades de desarrollo empresarial contribuyendo a propuestas, presupuestos y reuniones de defensa de ofertas. Entrenadores y mentores al otro personal de Biostatistica. Realiza otras tareas relacionadas con el trabajo conforme a sus asignaciones. Se puede requerir un mínimo viaje. Conozca Syneos Health Learn Durante los últimos 5 años, hemos trabajado con 94% de todos los medicamentos aprobados por la FDA Novel, 95% de EMA Authorized Products y más de 200 estudios sobre salud en 73.000 sitios webs y 675.000 pacientes de ensayo. No importa su papel, usted tomará una iniciativa muy dedicada y desafiará el statu quo en un entorno competitivo más adecuado. Las tareas básicas y laborales que se asignan. Si su experiencia pasada no se alinea perfectamente, le animamos a que aplique de todos modos. También le recomendamos unirse a nuestra Red de Talentos para mantenerse conectado con oportunidades profesionales adicionales. Descubra lo que nuestros 29.000 empleados ya saben: el trabajo aquí importa en todas partes. Trabajamos duro y inteligentemente para llevar terapias a los pacientes que las necesitan. Una carrera con Syneos Health significa que su trabajo diario mejora la vida global de los pacientes. Syneus Health® (Nasdaq: SYNH) es una organización líder integrada de soluciones biofarmacéuticas para acelerar el éxito del cliente. Traducimos información clínica, médica y comercial en resultados a las realidades modernas del mercado. Apoyamos una cultura diversa, equitativa e inclusiva. Teléfono: 919 876 9300 Fax: 919, 876 9360 T-Free: 866 462 7373 Syneo Salud es un Empleador Equal Opportunity Proces. Todos los solicitantes recibirán una solicitud legal sin tener en cuenta nuestro estatuto de origen, color, género o orientación sexual.