Job Description

Position Overview

This role is responsible for providing data to clients in a functional format, ensuring data accuracy and integrity, developing and maintaining clinical programming standard operating procedures, and ensuring project timelines are maintained. The position also involves contributing to team efforts and maintaining technical and industry knowledge.

Employment Type

• Full time

Primary Responsibilities

Data Provision and Validation

• Provides data to clients (internal and external) in functional format by:
  • Creating and executing SAS edit check programs
  • Validating edit check programs using standard validation practices and processes
  • Creating, validating, and executing SAS programs and macros
  • Utilizing SAS programming skills to provide ad-hoc reports (external and internal)
  • Assisting in developing programming specifications
  • Assisting in creating program specific validation plans
  • Identifying and implementing solutions for complex reporting needs

Data Accuracy and Integrity

• Ensures client data accuracy and integrity by:
  • Creating and/or reviewing data editing and export specifications
  • Working directly with clinical data managers, and where needed with clinical project managers and other team members to ensure specifications are clear and accurate.
  • Having a clear understanding of the contextual requirements for reporting outputs; and provides feedback
  • Programming data cleaning/consistency checking programs to support internal applications for all therapeutic areas
  • Programming and testing data export programs in accordance with specific client needs
  • Documenting all programming and validation efforts in accordance with Good Clinical Practices
  • Monitoring data integrity throughout a given study
  • Utilizing SDTM guidelines to create transfer datasets
  • Participating in project meetings (internal and external)

Clinical Programming Standards

• Develops and maintains clinical programming standard operating procedures by:
  • Participating in the development of data editing conventions, specification documents, and Clinical Data Management (CDM) processes
  • Contributing to, designing, and maintaining a library of reusable code
  • Leading and managing enhancements to current CDM systems and providing inputs in the implementation of new systems.

Timeline Management

• Ensures project timelines are maintained by:
  • Working independently and efficiently with minimal input required from the manager.
  • Reviewing timelines; and projecting estimates and target dates in conjunction with direct supervisor and project team
  • Adhering to target dates for project timelines
  • Communicating any changes in target date to appropriate personnel including Project Manager
  • Keeping department head informed of progress as well as potential impediments

Quality Service and Departmental Standards

• Maintains Quality Service and Departmental Standards by:
  • Adhering to established processes and standards
  • Reading, understanding, and adhering to organizational Standard Operating Procedures (SOPs)
  • Assisting in establishing and enforcing departmental standards
  • Maintaining and reviewing clinical programming SOPs
  • Participating in the modification of company SOPs

Secondary Responsibilities

Team Contribution

• Contributes to team effort by:
  • Working with internal staff to resolve issues
  • Exploring new opportunities to add value to organization and departmental processes
  • Helping others to achieve results
  • Performing other duties as assigned

Knowledge Maintenance

• Maintains Technical and Industry Knowledge by:
  • Attending and participating in applicable company-sponsored training

Qualifications

Education

• Bachelor’s or Master’s degree in computer science, life sciences, or related field required.
• SAS Certified Professional considered a plus.

Experience

• 3 years SAS programming experience in a pharmaceutical-related industry required (1 year with Master’s degree).
• Experience working with CDISC, SQL, and Relational Databases preferred.
• Demonstrated programming skills required.
• Working knowledge and solid understanding of database organization and how to extract data in order to generate listings and reports.
• Proven ability in analyzing data.
• Understanding of medical and/or clinical trial terminology is desirable.
• Proven ability in problem-solving.

Additional Skill Set

• Ability to work in a group setting and independently; ability to adjust to changing priorities.
• Excellent attention to detail and orientation toward meticulous work.
• Strong interpersonal and communication skills, both verbal and written.
• Strong documentation and organizational skills.
• Ability to project and maintain a professional and positive attitude.