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Provide statistical expertise for the development and support of innovative approaches to optimize the conduct and science of clinical trials, including use of synthetic control arms.
Leverage your statistical expertise and advanced programming skills to execute, manage and QC customer synthetic control arm projects and further develop innovative approaches to optimize clinical trials.
Create and review protocols, statistical analysis plans, and other study related documents. Work with the programming team to support, develop and review specification for different datasets, including SDTM/ADAM.
Work collaboratively 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
Perform, guide statistical programmers, and/or QC statistical analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming
Solid ability in the design, analysis, and interpretation of clinical trials, particularly in propensity score or other matching or weighting methods and/or Bayesian approaches to clinical trials with an appetite for innovation
Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
Regulatory submissions knowledge and experience utilizing define.xml and other submission documents. Understanding of FDA guidelines.
Strong SAS skills.
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
Your Education & Experience:
PhD degree or equivalent, in Statistics or Biostatistics, Exceptional candidates with MS degree in Statistics or Biostatistics may be considered
3+ years analyzing and interpreting clinical trials data and/or managing/QCing SAS programming in the Pharmaceutical & Biotech industry.
Experience working with and guiding statistical programmers
Experience in additional programming languages and/or Oncology trials preferred
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.