Statistical Programmer II

As a Statistical Programmer II at Syneos Health, you will play a crucial role in the generation of summary tables, data listings, graphs, and derived datasets using SAS or other software as per the statistical analysis plan and programming specifications. Your responsibilities will include: - Ensuring that outputs meet quality standards and project requirements. - Performing validation programming and collaborating with other Statistical Programmers and Biostatisticians to resolve discrepancies. - Keeping the project team informed of programming progress and addressing any issues requiring attention. - Following applicable SOPs, WIs, and regulatory guidelines such as ICH. - Maintaining well-organized project documentation and verification/quality control documents for inspection readiness. - Managing scheduling and time constraints across multiple projects, setting goals based on management priorities, and adapting to changes in timeline or priorities. - Developing specifications for datasets and outputs according to statistical and Sponsor requirements. - Anticipating and addressing potential programming issues, defining variables accurately for peer review with little rework. - Contributing ideas in internal meetings, respecting opinions of others, and collaborating with team members on various projects and initiatives. - Completing project programming activities within the allotted timeframe and assisting with the transfer of deliverables. - Acting as the Lead Statistical Programmer when required, directing programming activities and monitoring progress on deliverables. - Performing any other work-related duties as assigned with minimal travel requirements. Qualifications for this role include: - An Undergraduate Degree, preferably in a scientific or statistical discipline; or an equivalent combination of education and demonstrated programming experience. - Proficiency in programming in SAS or other required software, particularly in a clinical trial environment. - R programming skills and experience in Anonymization of Clinical Datasets are preferred. - Familiarity with SDTM/ADaM theoretical knowledge and hands-on experience will be beneficial. - Excellent written and verbal communication skills. - Knowledge of the drug development process (Phase I through IV) and general regulatory requirements. - Ability to manage multiple studies, with study lead experience. - Capability to read, write, speak, and understand English fluently. Syneos Health is dedicated to creating a diverse and inclusive work environment where every individual feels valued. With a focus on career development, technical training, and peer recognition, we aim to build a company that is not only great to work with but also great to work for. Join us in our mission to accelerate customer success and change lives through innovative solutions in the biopharmaceutical industry. Discover more about Syneos Health and the impactful work we do at http://www.syneoshealth.com. As a Statistical Programmer II at Syneos Health, you will play a crucial role in the generation of summary tables, data listings, graphs, and derived datasets using SAS or other software as per the statistical analysis plan and programming specifications. Your responsibilities will include: - Ensuring that outputs meet quality standards and project requirements. - Performing validation programming and collaborating with other Statistical Programmers and Biostatisticians to resolve discrepancies. - Keeping the project team informed of programming progress and addressing any issues requiring attention. - Following applicable SOPs, WIs, and regulatory guidelines such as ICH. - Maintaining well-organized project documentation and verification/quality control documents for inspection readiness. - Managing scheduling and time constraints across multiple projects, setting goals based on management priorities, and adapting to changes in timeline or priorities. - Developing specifications for datasets and outputs according to statistical and Sponsor requirements. - Anticipating and addressing potential programming issues, defining variables accurately for peer review with little rework. - Contributing ideas in internal meetings, respecting opinions of others, and collaborating with team members on various projects and initiatives. - Completing project programming activities within the allotted timeframe and assisting with the transfer of deliverables. - Acting as the Lead Statistical Programmer when required, directing programming activities and monitoring progress on deliverables. - Performing any other work-related duties as assigned with minimal travel requirements. Qualifications for this role include: - An Undergraduate Degree, preferably in a scientific or statistical discipline; or an equivalent combination of education and demonstrated programming experience. - Proficiency in programming in SAS or other required software, particularly in a clinical trial environment.