Associate Principal Scientist, Stat. Programming - A&R Standards, Innovation (Hybrid)
at Merck
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Job DescriptionIn 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.Responsibilities:This position supports the design, development, and delivery of efficient, flexible, and modular analysis and reporting and submission standards that can be used for drug and/or vaccine projects across all therapeutic areas. Adheres to standard operating procedures and guidelines established by the department. Drives data structures which includes analysis and reporting data standards and submission standards and actively contributes to the department's strategic initiatives.Primary Activities:Develop and validate global programming standards for ADaM datasetsDevelop and validate global programming standards for efficacy analysis and reportingDevelop and validate global programming standards for safety analysis and reportingDesign and develop complex programming algorithmsProvide technical consultation and analytical support to statistical programmers and statisticiansRepresent our company on relevant industry initiatives including R Consortium, TransCelerate, PHUSE, CDISC,. Collaborate with key stakeholders, partners in driving Analysis & Reporting standard programs using our company's standards, processesEducation and Minimum Requirement:BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus minimum of 9 years of SAS programming experience in a clinical trial environmentMS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 7 or more years of SAS programming experience in a clinical trial environmentDepartment Required Skills and Experience:Excellent interpersonal skills and ability to negotiate and collaborate effectivelyExcellent written, oral, and presentation skillsBroad knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, listings, figures)Strong project management skills; leadership at a program level; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholdersPosition Specific Required Skills and Experience:Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH and familiarity with at least one other statistical computing softwareKnowledge and understanding of CDISC SDTM and ADaM standardsExperience working with analytical research databases including various analysis datasets and procedures/packagesDemonstrated understanding of statistics, clinical trial, and data management concepts as applied to drug/vaccine development Demonstrated understanding of statistics, clinical trial, and data management concepts as applied to drug/vaccine development**Preferred Skills and Experience:Experience in developing flexible and efficient complex analysis and reporting standard SAS macrosR, Python and XML experienceExperience with Linked data, natural language processingExperience using SAS, R in Unix/Linux environmentAbility to comprehend analysis plans which may describe methodology to be programmed; understanding of statistical terminology and concepts; Implements statistical methods not currently available through commercial software packagesAbility and interest to work across cultures and geographiesActive in professional societieseligibleforERPSPjobsBARDS2020VETJOBSEBRG Required Skills: Accountability, Data Management, Data Modeling, Design Management, Mentorship, Numerical Analysis, Stakeholder Relationship ManagementPreferred Skills: Python (Programming Language), R ProgrammingCurrent Employees apply HERECurrent Contingent Workers apply HEREUS and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.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. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:EEOC Know Your RightsEEOC GINA SupplementWe are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.Learn more about your rights, including under California, Colorado and other US State ActsThe salary range for this role is$142,400.00 - $224,100.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.The successful candidate
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