SDC delivers top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005.
We are committed to providing experienced teams who will take ownership of your needs and are positively engaged in your projects.
With strategic scientific consulting and clinical data services (biostatistics, data management/EDC, and IRT/IWRS) expertise at our core, our services are scalable via our diverse and complementary strategic partnerships to provide full service clinical trial solutions.
Speak with us today to see why SDC is The Right Fit For You.®

SDC (Statistics & Data Corporation)

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data-engineer

SDC (Statistics & Data Corporation) is a specialized contract research organization (CRO) that provides technology-enabled services to the life sciences industry. Since 2005, SDC has been delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device companies. The company offers scalable clinical trial solutions, integrating their expertise in biostatistics, data management, and interactive response technology (IRT) with innovative software solutions such as eConsent, ePro, and EDC. SDC is renowned for its SDC DataHub, an AI-enabled data lake that ensures high data integrity and analytics capabilities. With a focus on empowering clinical decisions, SDC provides flexible and customizable services that support clinical trials from early-stage consulting to post-approval phases, all centralized around a data-driven ecosystem enhanced by SDC Insights.

SDC delivers top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. We are committed to providing experienced teams who will take ownership of your needs and are positively engaged in your projects. With strategic scientific consulting and clinical data services (biostatistics, data management/EDC, and IRT/IWRS) expertise at our core, our services are scalable via our diverse and complementary strategic partnerships to provide full service clinical trial solutions. Speak with us today to see why SDC is The Right Fit For You.®

**Job Summary**

The Senior Data Engineer will design and automate the cleaning, processing, and analyzing of both clinical data and nonclinical data with the goal of transforming data into information that supports better understanding of the safety and efficacy of new clinical therapies. The role contributes to the organization’s strong drive to be at the forefront of using Artificial Intelligence (AI) in clinical trials to simplify data processing and discover imperceptible correlations.

**Primary Responsibilities**

• 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

Senior Data Engineer automating cleaning and analysis of data for clinical trials at Statistics & Data Corporation. Engaging in AI initiatives to enhance data processing and insights.

clinical-research

• Apply a high level of technical expertise to help guide and develop the more junior biostatistics staff members.
• Serve as a lead statistician on clinical studies and provide senior level peer review of work being accomplished by other biostatisticians in the department.
• Maintain the statistical and analytical integrity of clinical trials analyzed by SDC.
• Actively participate in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, writing statistical sections of clinical study reports, and participating in meetings with drug regulatory agencies as required.
• Support business development and project management with strategic planning, proposals, pricing, and timeline planning.
• 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.

Principal Biostatistician

Principal Biostatistician focusing on clinical trials with leadership responsibilities at SDC. Guiding junior staff and ensuring quality standards in biostatistics analysis throughout projects.

• 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 designing data architecture and ETL frameworks for SDC's clinical services. Engaging in AI-driven approaches to enhance data processing and analysis for clinical trials.

SDC (Statistics & Data Corporation)

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Senior Data Engineer

SDC (Statistics & Data Corporation)

Principal Biostatistician

SDC (Statistics & Data Corporation)

Senior Data Engineer

SDC (Statistics & Data Corporation)