Clinical Data Standards Manager (SDTM)

Clinical Data Standards Manager (SDTM)

Division: Data Science - Acorn Reports to: Director, Data Science Medidata: a great place to work; a great place to stay Medidata: Conquering Diseases Together

Medidata is leading the digital transformation of life sciences, creating hope for millions of patients.

Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 1,400 customers and partners access the world's most-used platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systèmes company, is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at www.medidata.com.Your

Your Mission:

The Clinical Data Standards Manager is a key role on the Acorn AI Data Science team, composed of over 40 PhD/Masters statisticians, data scientists, analytical product leads, former FDA biostatisticians and computational genomicists. We leverage industry leading data assets and analytical models to transform the clinical development industry, driving scientific and operational success for our clients and partners. The Clinical Data Standards Manager will help drive the development and commercialization of new data-driven and cloud based analytics software products.

Use deep knowledge of clinical data management standards and systems to discover and map data elements from raw clinical trials data files to CDISC and internal standard data models and controlled terminologies to support construction of precision clinical analytics data assets and predictive models.

Serves as SDTM SME, supporting all SDTM programming and regulatory submission-related activities with vendors and internal team.

Lead and/or conduct QC of work described all the above that is done by others. Coordinates with vendors for SDTM development, develops/manages best practices for them and oversees their deliverables

Work with statisticians, data scientists, programmers, and project managers to understand and resolve clinical data standardization needs and meet customer project delivery deadlines.

Understand and convert analytical data requirements to data collection domain/variables following CDISC and internal data models and controlled terminologies.

Participate in reviewing hundreds of trials from multiple sponsors and make recommendations for data standardization rules.

Use internal tools to review outputs of data standardization algorithms and automated statistical reports on multiple pooled trials, validating mappings and making recommendations to improve data quality and model performance.

Perform ad hoc quality analyses on clinical trials data. Participate in the development of cross functional SOPs, Working Procedures and Guidance documents related to SDTM.

Serve as knowledge and training resource to internal teams on SDTM and clinical data capture practices.

Your Education & Experience:

BA/BS, Masters preferred, in a life science discipline.

Minimum 10 years progressive experience (at least 7 years in SDTM) at multiple companies in the pharmaceutical/CRO setting including depth in all the following:

SDTM development for submissions with full package

Clinical data manager or data standards manager including managing/using CT from CDISC and extending it as required

Participation in eCRF and EDC design

Clinical trials data collection and data QC processes

Requires extensive knowledge of Clinical Data Management, SDTM using/knowledge in latest version, and the creation of data mapping specifications.

Knowledge of data structures within clinical data management systems

Basic working knowledge of SAS or SQL for data exploration

Strong documentation, communication, and interpersonal skills

Prefer experience with oncology trials

Medical background is a plus

Prefer experience with pooled clinical trials data and/or Integrated analysis (ISS, ISE etc)

Prefer knowledge/experience in ADaM standards and development

Prefer experience with Medidata Rave

Prefer experience working with vendors

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 20,000 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.

EEO Statement

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.