SDC (Statistics & Data Corporation)

Data Engineer

• Designs and develops data architecture for new and existing applications and data sources
• Establishes Data Quality, Data Governance and Master Data Management Best Practices to enable the business to maintain clean and accurate data
• Designs ETL frameworks and features to allow for robust and scalable data pipelines
• Incorporates new pipelines into the existing data model, augmenting as needed
• Manages and maintains several production systems
• Engages with various internal cross-functional departments to strategically design, develop and implement data pipelines while understanding the underlying data
• Increases team productivity by developing, identifying, and implementing better tools and processes
• Exemplifies good documentation, coding, and testing best practices
• Develops standard operating procedures for the use of artificial intelligence and data engineering principles within clinical trials
• Prototypes new ideas/technologies to create proof of concept and demos
• Provides mentorship for other data engineers
• Assists in executing responsibilities of Data Engineers including the following:
• o Maintains and develops ETL pipelines
• o Maintains an Enterprise Data Warehouse by updating and translation logic and support warehouse servers.
• o Follows Data Quality, Data Governance and Master Data Management Best Practices
• o Delivers high quality software design documentation
• o Prototypes new ideas/technologies to create proof of concept and demos
• o Contributes to the development of standard operating procedures
• o Performs other related duties incidental to the work described herein
• Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements
• Act as a resource for other team members for debugging, code reviews and other software development lifecycle activities.
• Contract Research Organization experience and familiarity with its operations
• The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Senior Data Engineer

Clinical Research

• Serve as an internal consultant for biostatistics analysis tools and methods
• Serve as a subject matter expert during client and vendor meetings for biostatistics analysis support
• Actively support business development in capabilities presentations to prospective and current clients
• Effectively manage assigned clinical study budgets for biostatistics analysis support
• Develop, coach and mentor junior biostatistics department personnel
• Act as the lead statistician on clinical research projects and help with SAS programming
• Provide statistical expertise for study design of clinical trial protocols
• Write statistical methods section of the study protocol, as needed
• Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed
• Review CRFs to ensure consistency with protocol and statistical analysis plan (SAP)
• Program summary tables, data listings and graphical representations of clinical trials data
• Perform all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data
• Prepare/review key sections of clinical study reports and various regulatory documents
• Perform statistical QC of all department outputs including analyses and clinical study reports
• Provide statistical support to answer questions from external clients (such as FDA, Investigators)
• Contribute to the development, maintenance, and training of standard operating procedures (SOPs)
• Represent the biostatistics department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed
• Manage biostatistics timelines, budgets, and client expectations
• Adhere to all aspects of the Statistics & Data Corporation’s quality system
• Comply with Statistics & Data Corporation’s data integrity & business ethics requirements
• Perform other related duties incidental to the work described herein
• Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements

Senior Data Engineer

Principal Biostatistician