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Leverage your managerial, programming and statistical expertise, and solid ADaM and SDTM experience, to oversee the statistical programming team and assist in the development and support of innovative approaches to optimize clinical trials, including synthetic control arms.
Supervise a team of statistical programmers, manage workload and projects related to customer synthetic control arms
Manage/support team members in review of protocols, statistical analysis plans, and other study related documents to support accurate data mapping and statistical analysis. Manage/support team in review of specification for different datasets, SDTM/ADAM. Manage/support team in development of SAS programs to generate/validate variables and datasets.
Work collaboratively with team and with data standardization subject matter experts, statistical programmers and biostatisticians and other Acorn AI groups to assist in evaluating the accuracy of integrated historical data
Supervise team performing statistical analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming
A good understanding of the drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
Regulatory submissions experience utilizing define.xml (V2.0 released April 2014, V2.1 May 2019) and other submission documents. Understanding of FDA guidelines.
Strong SAS analysis and reporting skills. Solid experience implementing CDISC Standards (SDTM/ADaM). Proficiency in SAS MACRO development.
History of effective management of people or projects, especially statistical programming projects
Excellent written and verbal ability, including the ability to be persuasive to a technical or non-technical audience
Ability to work in a fast paced environment and work on multiple projects at the same time
Experience with ISS and ISE
Experience in Oncology trials a plus
Experience with multiple sponsors a plus
Your Education & Experience:
Master’s degree, PhD, or equivalent, in Statistics, Biostatistics or Mathematics
8+ years of statistical analysis and/or SAS programming experience in the Pharmaceutical & Biotech industry. Experience with additional programming languages a plus.
Medidata requires all U.S. employees to be fully vaccinated against COVID-19 and to provide documentation of full vaccination, unless qualified for an accommodation as determined by Medidata, consistent with applicable law. Although accommodation requests will be considered (and granted where appropriate/possible), it may be determined that a candidate is unable to adequately perform the essential functions of the position without imposing an undue hardship on Medidata due to customer requirements, staffing needs, or other business reasons.
Medidata Solutions, Inc. is an Equal Opportunity Employer. Medidata Solutions provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability status, protected veteran status, or any other characteristic protected by the law. Medidata Solutions complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.
MEDIDATA generates the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes.