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Reporting to the Manager, Statistical Programming, you will provide support for the industrialized standardization of historical clinical trial data using industry standards (e.g., SDTM, ADaM) and related processes. Working collaboratively with all the team leads you will provide high-quality, regulatory-compliant standardized data to improve clinical trials. The Principal Statistical Programmer will lead the analysis datasets development and also support the standardization of EDC data.
Be the ADaM expert, supporting SDTM and ADaM programming to create pooled analysis datasets for regulatory submission.
Work with biostatisticians and data analysts to understand the dataset requirements; document and program to create the analysis datasets.
Coordinate with vendors for ADaM development and oversee their deliverables
Perform ad hoc queries on raw and standardized data for selected baseline characteristics and summarize the results for statisticians, data engineers and project managers.
Research clinical trials in clinicaltrials.gov, Trialtrove, PubMed and other references to explore study characteristics
Help to improve the data standardization process with the automations and implementation of algorithms
Assist junior team members on ADaM development related activities and deliveries
Your Education & Experience:
Bachelor's degree in life science or a quantitative discipline required.
7+ years experience working with EDC data from variety of clinical trials across sponsors including hands-on work in and in-depth knowledge of all of the following:
Write/review ADaM specifications and programming/validate including efficacy domains
Analyze subject-level clinical trials data
Program and validate SDTM datasets
Read protocols, SAP, explore clinical datasets and make judgments about meaning and patterns in the data.
Require advanced skills in SAS base, macros and SQL; Programming knowledge in R or similar language is plus.
Prefer experience in oncology trials
Prefer experience with pooled clinical trials data and Integrated analysis (ISS and ISE)
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.