Senior Scientist, Statistical Programming

Responsibilities Support statistical programming activities for clinical trial data analysis. Develop SAS programs to create and validate analysis datasets (ADaM) and summaries (TFLs) in support of Clinical Study Reports and regulatory submissions (FDA, EMA, etc.). Collaborate with biostatisticians, project leads, and other stakeholders to ensure project plans are executed efficiently with timely and high-quality deliverables. Develop effective study and report programming and validation utilizing global CDISC, ICH, and Therapeutic Areas standards and following departmental SOPs and good programming practices. Maintain and manage a project plan including resource forecasting; coordinate activities of a global programming team; participate in departmental strategic initiative teams. Requirements Master's degree or equivalent in Computer Science, Statistics, Applied Mathematics, Biomedical Engineering, or a closely related field and 3 years of experience in the position offered or a related role; OR a Bachelor's degree or equivalent in Computer Science, Statistics, Applied Mathematics, Biomedical Engineering, or a closely related field and 5 years of experience in the position offered or a related role. Must have 3 years of experience with all the following: Developing analysis and reporting deliverables for Phase 2 and 3 clinical trials, including creation of analysis datasets, tables, graphics, and listings, for planned and unplanned analyses. SAS programming in a clinical trial environment including data step and procedures, macros, graphics, ODS. Interpreting and executing on clinical trial statistical analysis plans. Utilizing CDISC standards to create ADaM and SDTM datasets. Designing and developing complex programming algorithms. Ensuring process compliance and deliverable quality. US and Puerto Rico Residents Only As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. San Francisco Residents Only We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance. Los Angeles Residents Only We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Employee Status Regular Relocation No relocation VISA Sponsorship No Travel Requirements No Travel Required Flexible Work Arrangements Not Applicable Shift Not Indicated Valid Driving License No Hazardous Material(s) n/a #J-18808-Ljbffr Merck & Co.