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MSD Malaysia

Sr. Scientist, Statistical Programmer- Late-Stage, Hybrid

MSD Malaysia, Trenton, New Jersey, United States

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* The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.* The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high-quality deliverables.* For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle.* BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years SAS programming experience in a clinical trial environment* MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3 years SAS programming experience in a clinical trial environment* Effective interpersonal skills and ability to negotiate and collaborate effectively* Effective written, oral, and presentation skills* Effective knowledge and experience in developing analysis and reporting deliverables for Research & Development projects (data, analyses, tables, graphics, listings)* A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders* Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise* Preferred qualifications include hands-on experience using R and Python for data analysis.* Designs and develops complex programming algorithms* Ability to comprehend analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts* Familiarity with clinical data management concepts* Experience in CDISC and ADaM standards* Experience ensuring process compliance and deliverable quality* Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices* Ability to anticipate stakeholder requirements* Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life cycle (SDLC)* US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables* Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a programming mentor* Ability and interest to work across cultures and geographies* Ability to complete statistical programming deliverables through the use of global outsource partner programming staff* Experience developing and managing a project plan using Microsoft Project or similar package* Active in professional societies* Experience in process improvement**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 #J-18808-Ljbffr