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Our team is responsible for the scientific development of the concept of a synthetic control arm and the delivery of customer synthetic control arm projects which often affect our customer’s most important programs. Our customers (most often medical product or device clinical development teams) depend on us for high quality external controls created using sound statistical methodology and expertise in the justification and use of synthetic controls in a regulatory setting. We often present our synthetic control arm work in clinical or statistical professional meetings or publications in scientific journals. Collaborations with other researchers in academia, the pharmaceutical industry, or regulatory space are common. Our work is highly innovative with clear impact to patients.
Who we’re looking for:
We seek a candidate who can
Assist in the development and support of innovative approaches to optimize the conduct and science of clinical trials, especially concerning the use of Synthetic Control Arms (SCA). An SCA is an external control created using appropriate statistical methods to achieve baseline balance and to augment clinical trials with patient level data from previous clinical trials. Medidata has access to thousands of previous clinical trials available in the Medidata Enterprise Data Store which may be the basis of this work.
Provide statistical expertise in carrying out customer SCA projects in the regulatory and nonregulatory setting, including development of SCA statistical analysis plans, assessment of the adequacy of the available historical clinical trials data to fulfill the SCA research objective, guiding the standardization of data assets and overseeing statistical model building, selection generation of comparative analyses in the interpretation and QC of SCA data analyses and overall conclusions.
Provide statistical expertise including but not limited to research in statistical methods, participation in scientific publication or presentation, and case study data analyses to support the overall SCA program.
Work collaboratively with members of the data standardization team, statistical programming and other Acorn AI groups to assist in carrying out SCA projects.
May present at internal or external meetings or communicate findings through written reports.
Requirements (Education & Experience):
Typically requires a PhD in Biostatistics or Statistics with approximately 10 to 15 years of related experience in the pharmaceutical industry and/or regulatory (e.g. FDA) context analyzing and interpreting clinical trials data
Regulatory submissions experience. Awareness of typical drug development processes, including for example the regulatory interactions expected at each phase of development and the level of evidence generally required for approval of a new medical product, experience in the Phase II/III oncology therapeutic area is a plus
Strong ability in the design, analysis, and interpretation of clinical trials and clinical research
Strong statistical and analytical skills, particularly in time-to-event analyses, propensity score or other matching or weighting methods and/or Bayesian approaches to clinical trials with an appetite for innovation
Excellent written and verbal ability, including the ability to be persuasive to a technical or non-technical audience
Ability to work independently in a fast paced environment and work on multiple projects at the same time
Ability to manage and oversee outsourced staff and works
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.