Senior Biostatistician

Join to apply for the Senior Biostatistician role at Catalyst Clinical Research As a Senior Biostatistician you are a key member of the Oncology Operations Biostatistics Team. The Senior Biostatistician will serve as a primary statistical representative for biometrics standalone projects or otherwise complex studies. You will effectively manage broad based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations. You will develop and review statistical analysis plans based on study specific documents and sound statistical methodology. Assist in developing and maintaining ADaM specifications used in creating analysis datasets, tables, listings, and figures. Have senior oversight to junior level biostatistics staff. Position Responsibilities :Lead low to high complexity studies in various phases of development. Provide senior oversight on low or moderate complexity studies .Effectively manage broad based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple projects simultaneously .Collaborate with internal and external project team personnel (e.g., Sponsor company, external vendors, and within Catalyst Clinical Research) as needed to meet project deliverables and timelines for statistical data analysis and reporting .Interact with project team and line manager to identify project priorities and communicate such activities and associated timelines to departmental management .Serve as primary statistical representative for biometrics standalone projects or otherwise complex studies .Represent department and company in a multi-disciplinary setting, including project team meetings, client meetings/presentations, and/or bid defense meetings .Provides statistical advice/recommendations regarding clinical study design/study endpoints, sample size requirements, statistical methodology for the study protocol and clinical study report, and document review/approval .Develop and review of statistical analysis plans based on study specific documents and sound statistical methodology .Assist in developing and maintaining ADaM specifications used in creating analysis datasets, tables, listings, and figures .Ensure the quality and integrity of data analysis and reporting by programming checks using SAS .Monitor project budgets as it relates to the scope of work and support project forecasting efforts. Meet with members of Finance to assess project budgets and report study status .Contribute to departmental objectives and strategies Position Qualification Education n:Master’s degree, equivalent, or higher in biostatistics or a related fiel d.A satisfactory combination of education and experience may be accepted as a substitute for the specific education and experience listed abov Experience ce: A minimum of 5+ years of relevant work experie nce.Previous experience in pharmaceutical research or CRO setting requi red.Prior experience in multiple therapeutic areas required, with experience in Oncology prefer Required Sk ills:Knowledge of clinical trial study design and multiple therapeutic a reas.Able to work independently on multiple, concurrent proj ects.Lead study team meetings as ne eded.Capable of conducting exploratory statistical analyses using statistical software pack ages.Proficient with Microsoft Office S uite.Excellent written and oral communication sk ills.Strong organizational, problem-solving, and analytical sk ills.Ability to manage priorities and work flow.Versatility, flexibility, and a willingness to work within constantly changing priori ties.Proven ability to handle multiple projects and meet deadl ines.Ability to deal effectively with a diversity of individuals at all organizational le vels.Commitment to excellence and high stand ards.Creative, flexible, and innovative team pl ayer.Good judgement with the ability to make timely and sound decis ions.Ability to travel for meetings or training activi ties.Ability to program simple checks for ADaM or TLF review using SAS and/ Seniority level Mid-Senior level Employment type Full-time Job function Analyst and Research Industries Research Services and Biotechnology Research Location: Madrid, Community of Madrid, Spain #J-18808-Ljbffr