Job Description

Overview Join to apply for the Senior Biostatistician role at Capgemini Engineering Get AI-powered advice on this job and more exclusive features. Your Role The Senior Biostatistician collaborates with team members (both internal and external) to provide high-quality, reliable statistical expertise and support. They perform and oversee quality control (QC) of data displays with inferential statistics. Senior Statisticians conduct QC analyses of datasets prepared by others, and maintain project administration files (including protocols, annotated CRFs, statistical analysis plans, annotated shells, programming/QC rules, tracking logs, and project communications). Contribute to design, analysis and reporting of clinical trials or other scientific research studies. Assist with development of protocols, statistical analysis plans and/or Table, Figure, and Listing shells with details for execution and programming implementation. Work under supervision to implement sound statistical methodology in scientific investigations. Write and review SDTM and ADaM specifications for moderately complex studies. Perform production and/or validation programming of SDTM, ADaM and TLFs for moderately complex studies. Assist in identifying scientifically appropriate data collection instruments. Identify and report data issues or violations of study assumptions. Provide programming specifications for derived variables and analysis datasets. Collaborate with team members in preparation for database lock. Maintain a working knowledge of regulatory guidelines regarding clinical trial analysis and reporting. With supervision, perform statistical analyses as per the analysis plan. Collaborate with Statistical Programming to ensure the delivery of high-quality outputs according to agreed upon timelines. Evaluate the appropriateness of available software for planned analyses and assess needs for potential development of novel statistical methodology. With supervision, develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures. Ensure the accuracy of the statistical component of scientific reports and/or publications with high quality. Work collaboratively with cross-functional teams. Clearly explain statistical concepts to non-statisticians. Provide responses to questions and pursue analyses suggested by data under supervision. Build/drive cross-functional relationships and collaboration. Collaboration with US time zones to support periodic sponsor meetings and internal questions and meetings. Your Profile Master’s degree in statistics, biostatistics or closely related fields, PhD preferred. Master with 4+ years (PhD 1+ year) of industry experience as a Study Statistician Ability to lead projects and manage team members and work collaboratively, effectively, and productively in diverse organization structures. Solid statistics background and training, working knowledge of advanced statistical methodologies and SAS programming skills; good understanding of drug development and experiences with clinical trial data analyses/preparation for submissions; good knowledge and understanding of regulatory guidelines Advanced knowledge of SAS procedures. Location: Portugal (Relocation Mandatory) What You\'ll Love About Working Here Join a multicultural and inclusive team environment. Enjoy a supportive atmosphere promoting work-life balance. Hybrid work. Your career growth is central to our mission. Our array of career growth programs and diverse professionals are crafted to support you in exploring a world of opportunities. Access valuable training and certifications in cutting-edge technologies. Engage in exciting national and international projects. Health and life insurance. Referral program with bonuses for talent recommendations. Great office locations. About Capgemini Choosing Capgemini means choosing a company where you will be empowered to shape your career in the way you’d like, where you’ll be supported and inspired by a collaborative community of colleagues around the world, and where you’ll be able to reimagine what’s possible. Join us and help the world’s leading organizations unlock the value of technology and build a more sustainable, more inclusive world. Seniority level Mid-Senior level Employment type Full-time Job function Research, Analyst, and Information Technology #J-18808-Ljbffr Capgemini Engineering

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