Medidata: Powering Smarter Treatments and Healthier People

　　Medidata, a Dassault Systèmes company, is leading the digital transformation of life sciences, creating hope for millions of people. 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 2,000+ customers and partners access the world's most trusted platform for clinical development, commercial, and real-world data. Known for its ground-breaking technological innovations, Medidata has supported more than 30,000 clinical trials and 9 million study participants. And Medidata's ongoing commitment to infusing the patient voice into trial designs and solutions is helping to create a better and more inclusive experience for all participants in clinical studies. Medidata is involved in nearly 40% of company-initiated trial starts globally, with studies conducted in more than 140 countries. More than 70% of novel drugs approved by the Food and Drug Administration (FDA) in 2022 were developed with Medidata software. Medidata 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 and follow us @medidata.

　　Technical Services at Medidata is seeking a Principal Data Engineer to develop high-quality data engineering services and tools for our clients. The ideal candidate will have a deep understanding of data management in the context of clinical trials, deep working experience in software development, infrastructure, cloud, data engineering, and experience developing tools for data reconciliation across different data sources and modalities.

　　Our technology is in an industry that is improving the lives of millions. Collect our client's data from different modalities into our platform and make them available wherever and whenever customers need it, safely and reliably. There is no room for error. If you are looking for a better place to use your passion and your desire to drive change, this is the place to be. As part of the Technical Services team, the successful candidate will play a significant part in being a data engineer/data management trusted advisor across all clients.

　　You will be supporting the technology data and analytics to improve stakeholder engagement, idea intake, roadmap management and optimal data related to product performance while ensuring execution and delivery transparency. In this role you will actively contribute and influence how ideas and strategy become a reality; directly impacting clinical and business practices. You will make a difference solving the impossible.

　　Position in this function is responsible for the full data lifecycle management, including design, prioritization, development cycle management for end-of-life, new, existing and acquisition products.

　　Leverage market insights to understand market/customer needs to identify new opportunities or make adjustments to current TS data offerings. The key to a successful offering is to ask why, to use frameworks and models building solid relationships across business and technology.

　　The ideal candidate will have the right balance between data strategy, data engineering and execution.

　　The Principal Data Engineer assists the VP of Technical Services to define and execute the data strategy within Technical Services and is responsible for the growth goals the data of a

　　related product portfolio achieves annually.

　　Data Engineering Expertise: The candidate should have extensive experience in data engineering, particularly in the context of clinical trials. This includes proficiency in ETL (Extract, Transform, Load) processes, data reconciliation across different data sources, and managing the full data lifecycle.

　　Software Development and Infrastructure Knowledge: The ideal candidate should possess a strong background in software development, infrastructure, and cloud technologies. This is crucial for developing data engineering tools and solutions and ensuring they are efficient and reliable.

　　Data Management and Regulatory Knowledge: The candidate must have in-depth knowledge of data management practices, including regulatory requirements related to clinical trials, such as FDA guidance documents and CDISC standards. Understanding good clinical practices (GCP), protocol, and SDTM mapping is essential.

　　The day-to-day responsibilities for this person would include:

　　Developing and maintaining a data vision and roadmap.Prioritizing backlog and ensuring stakeholders are informed.Managing cross-functional stakeholders, including design, engineering, scrum teams, and business leaders.Creating data as a product Business Cases to support planning.Presenting data opportunities in leadership discussions with the VP of Technical Services.Implementing data engineering strategies that align with the company's business goals.Leading data reconciliation efforts across various data sources and modalities.Ensuring data engineering processes are efficient, effective, and compliant with regulatory requirements.Providing technical leadership in software development, infrastructure, cloud, and data engineering.Identifying opportunities for process improvement and new technology adoption.Developing and maintaining digital health data pipelines.Collaborating with data scientists on healthcare data ingestion solutions.Working on data analytics, machine learning, and data visualization.Ensuring data privacy and anonymization.Integrating various data collection modalities into clinical development programs.Utilizing data handling strategies to address data quality issues and outliers.Driving process optimization and pattern recognition.Supporting the development of tools for data insights and validation.Having a high-level understanding of artificial intelligence methods.

　　The role involves collaboration with various cross-functional teams, including design, engineering, and data science. This is a senior individual collaborator job

　　Requirements:

　　- 5+ years of experience in a leadership role within a sponsor or CRO organization

　　- Expertise in software development, infrastructure, cloud, data engineering, and data reconciliation

　　- Strong project management skills and experience managing cross-functional teams

　　- Excellent communication skills and the ability to work effectively with both technical and non-technical stakeholders

　　- Knowledge of regulatory requirements related to data management in clinical trials, including FDA guidance documents and industry standards such as CDISC

　　- Pushing for new ways to use data engineering in data management, with experience in technological adoption

　　- Guiding regarding software applications that manage data.

　　- 5+ years of demonstrable experience on defining data strategy, roadmap, requirements and translate into artifacts that drive data management. This includes market evaluation, persona development, capability and journey mapping

　　- 5+ years' experience in defining the product vision, goals, benefits and then track KPI's to measure success/outcomes

　　- The candidate must understand good clinical practices (GCP), protocol, protocol deviations, metadata, basic SDTM mapping, programming

　　- Having prior Sponsor/CRO experience you will be a proactive advisor to let clients know what is possible, based on the Medidata products and platform capabilities communicating effectively with the client organizations recommending solutions

　　- The key role is that the candidate should be aware of how study data should be processed, how systems should be configured and validated to get true data that can fit the protocol endpoints.

　　- Strong communication and planning skills

　　- Work more independently and autonomously

　　- Represent the culture of performance, collaboration and opportunity.

　　The candidate sholud have an MS Degree or equivalent work experience in field.

　　The salary range for positions that will be physically based in the NYC Metro Area is $184,500-246,000.

　　Base pay is one part of the Total Rewards that Medidata provides to compensate and recognize employees for their work. Most sales positions are eligible for a commission on the terms of applicable plan documents, and many of Medidata's non-sales positions are eligible for annual bonuses. Medidata believes that benefits should connect you to the support you need when it matters most and provides best-in-class benefits, including medical, dental, life and disability insurance; 401(k) matching; unlimited paid time off;and 10 paid holidays per year

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　　Equal Employment Opportunity

　　In order to provide equal employment and advancement opportunities to all individuals, employment decisions at Medidata are based on merit, qualifications and abilities. Medidata is committed to a policy of non-discrimination and equal opportunity for all employees and qualified applicants without regard to race, color, religion, gender, sex (including pregnancy, childbirth or medical or common conditions related to pregnancy or childbirth), sexual orientation, gender identity, gender expression, marital status, familial status, national origin, ancestry, age, disability, veteran status, military service, application for military service, genetic information, receipt of free medical care, or any other characteristic protected under applicable law. Medidata will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.