Merck
Scientist, Statistical Programming-PKPD (Hybrid PA/NJ)
Merck, Rahway, New Jersey, United States, 07065
Statistical Programmer
In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the-art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders in Early and Late Development PK/PD modeling and simulation stakeholders spanning both early and late-stage Oncology studies. Accountability predominantly includes the development and execution of statistical/modeling datasets, tables, listings, figures and regulatory submission deliverables under the guidance of senior level programmer. The Statistical Programmer will perform development and/or validation tasks according to departmental SOPs and collaborate effectively with stakeholders (Statistician, modelers, clinical team), other functional areas and outsource partners. Primary Activities: Programmatically develop, validate and maintain modeling datasets, tables, listings and figures at study/protocol level Assure deliverables quality and compliance with departmental SOPs and good programming practices Collaborate effectively with project team members including outsource provider staff Ensure programmatic traceability from data source to analysis/modeling result Support the development of programming standards to enable efficient and high-quality production of programming deliverables Represent statistical programming on process improvement activities Education: BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 2 years SAS programming experience in a clinical trial environment MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field Department Required Skills and Experience: Good interpersonal skills and ability to negotiate and collaborate effectively Good written, oral, and presentation skills Knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings) Takes direction effectively and completes tasks at a project level; ability to collaborate with key stakeholders Position Specific Skills and Experience: Experience with at least one other software than SAS (e.g., R, Python) Familiarity/experience with pharmacokinetic data and modeling and simulation datasets and analyses. SAS programming experience including data steps, procedures, data manipulation, SAS/MACRO, SAS/GRAPH Ability to quickly and effectively learn new program techniques and data structures Takes direction effectively and completes programming tasks under the guidance of a senior programmer at a project level Knowledge in CDISC SDTM and ADaM standards An interest to advance career by investing in development activities and taking on tasks with increasing levels of challenge and responsibility Preferred Skills: Knowledge of pharmaceutical development processes and clinical endpoint data (efficacy and safety) Good working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC) Ability and interest to work across cultures and geographies.
In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the-art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders in Early and Late Development PK/PD modeling and simulation stakeholders spanning both early and late-stage Oncology studies. Accountability predominantly includes the development and execution of statistical/modeling datasets, tables, listings, figures and regulatory submission deliverables under the guidance of senior level programmer. The Statistical Programmer will perform development and/or validation tasks according to departmental SOPs and collaborate effectively with stakeholders (Statistician, modelers, clinical team), other functional areas and outsource partners. Primary Activities: Programmatically develop, validate and maintain modeling datasets, tables, listings and figures at study/protocol level Assure deliverables quality and compliance with departmental SOPs and good programming practices Collaborate effectively with project team members including outsource provider staff Ensure programmatic traceability from data source to analysis/modeling result Support the development of programming standards to enable efficient and high-quality production of programming deliverables Represent statistical programming on process improvement activities Education: BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 2 years SAS programming experience in a clinical trial environment MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field Department Required Skills and Experience: Good interpersonal skills and ability to negotiate and collaborate effectively Good written, oral, and presentation skills Knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings) Takes direction effectively and completes tasks at a project level; ability to collaborate with key stakeholders Position Specific Skills and Experience: Experience with at least one other software than SAS (e.g., R, Python) Familiarity/experience with pharmacokinetic data and modeling and simulation datasets and analyses. SAS programming experience including data steps, procedures, data manipulation, SAS/MACRO, SAS/GRAPH Ability to quickly and effectively learn new program techniques and data structures Takes direction effectively and completes programming tasks under the guidance of a senior programmer at a project level Knowledge in CDISC SDTM and ADaM standards An interest to advance career by investing in development activities and taking on tasks with increasing levels of challenge and responsibility Preferred Skills: Knowledge of pharmaceutical development processes and clinical endpoint data (efficacy and safety) Good working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC) Ability and interest to work across cultures and geographies.