SDC (Statistics & Data Corporation)

Software Engineer

• Provide statistical programming support to clinical trials. Produce statistical analyses, including generating/validating analysis datasets, tables, listings, and figures for clinical trials. Create SDTM mapping and datasets. Develop and maintain the infrastructure for project files of SAS datasets and SAS code. Support Data Management in data set creations/transfers, integrity checks, and quality audits. Act as a liaison between clinical and subcommittees and project teams on an as-needed basis.
• Perform or oversee team in performing all statistical programming required for clinical trial analysis and reporting on large scale projects of high complexity
• Apply appropriate statistical methods for data analysis and provide statistical programming expertise for project teams
• Review the Statistical Analysis Plan in preparation for programming the planned analyses
• Lead design/development of SAS macros and other utilities to expedite SAS programming activities
• Organize and conduct internal training sessions and author papers for conferences
• Generate tables, listings, and figures per protocol, Statistical Analysis Plan, and/or approved client request
• Participate in statistical program validation and quality control activities
• Develop or review SDTM aCRF and specifications, ADaM specifications; complete programming and validation of CDISC SDTM and ADaM datasets
• Review pinnacle 21 reports and ensure compliance with CDISC and FDA guidelines
• Develop define.xml, study data reviewers guide and analysis datasets reviewers guide
• Identify study priorities and communicate effectively with project team and management
• Ensure quality, proper documentation and meet or exceed timely completion of the project within budgeted hours
• Manage statistical programming timelines, budgets, and client expectations
• Actively participate in study team meetings
• Interact with other departments, such as Clinical Operations, Project Management, and Data Management to ensure a high level of client satisfaction through successful execution of projects
• Participate in review process of study documents such as the CRF, edit check specifications, and database design specifications written by Data Management
• Program data cleaning checks, as necessary, to assist Data Management’s data cleaning activities
• Participate in installation/validation of statistical software packages throughout the software development lifecycle
• Develop and maintain the infrastructure for project files of SAS datasets and SAS code
• Mentor junior level statistical programmers by developing training plans and providing oversight of their work
• Ensure all programming activities and processes performed are conducted according to SDC’s standard procedures and/or sponsor requirements
• Contribute to the development of standard operating procedures for statistical programming
• Adhere to all aspects of the SDC’s quality system
• Comply with SDC’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 Statistical Programmer

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.

Principal Biostatistician

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.

Principal Statistical Programmer

Principal Biostatistician

Senior Data Engineer