Medidata Solutions, Inc. SDTM Quality Analyst in United States
Medidata is leading the digital transformation of life sciences with the world's most-used platform for clinical development, commercial and real-world data. Powered by artificial intelligence and delivered by #1 ranked industry experts, the Intelligent Platform for Life Sciences helps pharmaceutical, biotech, medical device companies and academic researchers accelerate value, minimize risk and optimize outcomes. Medidata serves more than 1,000 customers and partners worldwide and empowers more than 100,000 certified users every day to create hope for millions of patients. Discover the future of life sciences: www.mdsol.com
We know that diverse teams win and are fully committed to selecting leaders and employees that represent the markets in which we operate. We are still led by our Co-founders, Tarek Sherif and Glen de Vries, and have global operations in US, Europe and Asia with over 2000 employees.
Use deep clinical/EDC data knowledge and QC procedures to QC SDTM and ADaM datasets.
Map the data elements from raw clinical trials data files to standard variables
Search study specific EDC datasets to look for patients that meet certain criteria
Read and interpret results of clinical trials on publicly available sources such as clincialtrials.gov, PubMed and FDA website.
Review standardizations across thousands of trials from multiple sponsors and make recommendations.
Use analytic programming tools (SAS or R, in house) to do exploratory data analysis.
Document and summarize QC results for statisticians, data engineers, and project managers.
Run, review, publish, and support automated data summaries.
Your Education & Experience:
BA/BS, Master’s degree in life science or a quantitative discipline required.
Minimum 5 years working with clinical data including hands-on work in, and deep knowledge of, all of the following:
Clinical trials data collection design and process (eCRF, EDC)
Clinical data QC processes and methods, including statistical and programmatic approaches
Analysis of subject-level clinical data
Requires intermediate skills in SAS or R or Python for data exploration.
Good documentation, communication and interpersonal skills.
Ability to explore clinical datasets and complex scientific documents and make sophisticated judgments about meaning of, and patterns in, data.
Prefer experience/knowledge of SDTM and ADaM standards.
Prefer work experience at multiple pharmaceutical research companies.
Prefer experience with oncology trials.
Medidata is making a real difference in the lives of patients everywhere by accelerating critical drug and medical device development, enabling life-saving drugs and medical devices to get to market faster. Our products sit at the convergence of the Technology and Life Sciences industries, one of most exciting areas for global innovation. Nine of the top 10 best-selling drugs in 2017 were developed on the Medidata platform.
Medidata’s solutions have powered over 14,000 clinical trials giving us the largest collection of clinical trial data in the world. With this asset, we pioneer innovative, advanced applications and intelligent data analytics, bringing an unmatched level of quality and efficiency to clinical trials enabling treatments to reach waiting patients sooner.
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.