Job Description

CDISC Specialist

Statistics & Data Corporation (SDC), A global contract research organization (CRO) headquartered in Arizona, providing clinical trial solutions for pharmaceutical, biologic, and medical device/diagnostic companies since 2005. Our core expertise is strategic scientific consulting and clinical data services which include biostatistics, data management/EDC, and IRT/IWRS.

Job Summary:
Develop internal standards for the CDISC deliverables. Create or review SDTM/ADaM mapping documents and output. Provide statistical programming support to clinical trials by producing statistical output, including generating/validating SDTM, analysis datasets, tables, listings, and figures for clinical trials. Develop and maintain the infrastructure for project files of SAS datasets and SAS code. Support Data Management in data set creation/transfers, integrity checks, and quality audits. Act as a CDISC expert and provide CDISC consulting and training as needed.

Primary Responsibilities

• Lead and/or participate in developing or improving internal standards for all CDISC deliverables including SDTM, ADaM, reviewers guides, SDTM-annotated CRFs, and Define.xml
• Work with the study teams to ensure CDISC compliance across all clinical trial inputs, including database design and external data transfers
• Organize and conduct internal training sessions and author papers for conferences
• Serve as point-of-contact for CDISC-related questions and electronic submissions
• Monitor electronic submission requirements and develop/modify procedures to comply with requirements.
• Develop/review SDTM mapping documents and ADaM Specifications; complete programming and validation of SDTM and ADaM datasets
• Assist in the development of AI and machine learning algorithms for SDTM specifications and datasets
• 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
• Generate tables, listings, and figures per protocol, Statistical Analysis Plan, and/or approved client request
• Participate in statistical program validation and quality control activities
• Identify study priorities and communicate effectively with project team and management
• Ensure quality, proper documentation and timely completion of the project within budgeted hours
• 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
• Develop and maintain the infrastructure for project files of SAS datasets and SAS code
• Ensure all programming activities and processes performed are conducted according to SDC's standard procedures and/or sponsor requirements
• 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

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.

Requirements

Required Skills

• Expert knowledge of CDISC SDTM and ADaM data models and electronic submissions
• Up-to-date familiarity with FDA/PMDA guidance and standards pertaining to data standards and electronic submissions
• Leadership skills and ability to train others on current standards and best practices
• Strong analytical skills, with the ability to process scientific and medical data
• Very strong SAS programming skills required, with proficiency in SAS/Base, SAS/Stat, SAS Macros and SAS/Graph
• Strong problem-solving skills
• Able to work independently and proactively
• Excellent knowledge of statistical programming
• Proficient in manipulating and analyzing SAS data
• Ability to identify data issues, present problems, and implement solutions quickly
• Capability of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues
• Good organizational and time management skills, with the ability to multi-task
• Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)
• Very strong interpersonal communication and presentation
• SAS Base, Advance and Clinical Trials Certification is preferred

Education or Equivalent Experience

• Bachelor's degree in computer science, statistics or other related, scientific field and at least 6 years of relevant professional experience including at least 2 years of experience with CDISC SDTM and ADaM; or an equivalent combination of relevant education and/or experience.