Biostatistician II

Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us! SUMMARY: The Biostatistician II is a key member of the Clinical Development Operations, Biostatistics Team. The Biostatistician will plan, analyze, and summarize the results of individual clinical studies or groups of studies, coordinate the development and review of regulatory submissions, and program and/or review statistical tables, listings, figures, and analysis datasets for clinical trials.  RESPONSIBILITIES: Tasks may include but are not limited to: Work with project team personnel and vendors to meet project deliverables and timelines for statistical data analysis and reporting. Provide sample size calculations and review protocols for completeness. Provide randomization schemes and appropriate documentation per SOPs. Monitor project budgets and support project forecasting efforts. Serve as project manager when a clinical development PM does not exist. Contribute to departmental initiatives. Serve as subject matter expert for the Biostatistics and Programming teams. Provide statistical advice regarding study design, endpoints, sample size requirements, and methodology. Author statistical analysis plans and study specifications. Serve as the primary statistical contact for the study/project team. Use knowledge of regulatory agency requirements and guidance documents to support clinical development programs. Use knowledge of literature to provide data analysis and presentation methods to support publications and presentations. Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. OTHER SKILLS AND ABILITIES: Knowledge of clinical trial study design. Able to work independently on multiple…