Principal Scientist, Clinical Trials
vor 1 Tag
MSD is a research-driven biopharmaceutical company dedicated to creating medicines that make a significant impact on patient outcomes. Our mission is built on the simple premise that if we 'follow the science' and invent medicine and vaccine innovations that make a difference for patients across the globe. We are committed to advancing medical science and fostering a culture of innovation within our organization.
Job Description
We are seeking a Principal Scientist, Clinical Trials to join our Biostatistics and Research Decision Sciences (BARDS) organization. As part of our team, you will be responsible for providing statistical leadership and support to projects in the BARDS HTA Statistics group, including HTA submissions. You will interact with multidisciplinary scientists, company subsidiary project leads, and Late Development Statisticians to support HTA submissions. You will also design, develop, and evaluate tools and methods for HTA evaluations, give input to V&I teams as a statistical representative, lead and provide statistical support to cross-functional teams preparing HTA submissions, and plan and execute independently on ongoing HTA evaluations, including analysis and interpretation of HTA results. Ensure that project deliverables meet analysis and submission requirements. Additionally, you will collaborate with Statistical Programming lead to implement methodologies and ensure high-quality deliverables for HTA submissions, prepare written reports to effectively communicate results of HTA evaluations to cross-functional stakeholders, design, develop, and apply HTA methods, processes, and standard tools, and provide responses for queries from HTA agencies related to statistical analyses and methodological rationale.
Requirements
To be successful in this role, you will need a PhD or equivalent degree in statistics/biostatistics or a related discipline with a minimum of 6 years relevant work experience, or Master's with a minimum of 9 years relevant work experience, or bachelor's with at least 15 years relevant experience. You will require good knowledge of biostatistical methodologies and experimental design, working knowledge of statistical and data processing software, e.g., SAS and/or R, team-oriented collaboration skills, and strong communication skills. Experience in CDISC data standards (SDTM, ADAM), understanding of biology of disease and drug development, publication record in peer-reviewed statistical/medical journals, managing teams, performance management, effective communication skills, and ability to develop people and teams are also essential.
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