R&D Programmer II

Job Title: Clinical Programming Contractor
Location: 100% Remote
Type: Contract
Duration: Up to 2 year assignment
Shift Schedule: Regular 40-hour work week (morning shift)
Position Summary
The Clinical Programming (Contractor) is responsible for providing comprehensive programming support, including managing the timely and accurate execution of programming components of clinical trials.
The clinical programming contractor independently manages completed projects that involve global tasks or cross-functional teams. The role may require providing inputs to design and analysis, and reporting the results of clinical trials, including programming rules and mocked T/L/G. In addition, providing programming support for publication for marketed drugs.

• Travel Requirements: N/A

Core Essential Skill Sets

1. Bachelor's Degree + 5 years OR Master's Degree + 4 years of professional experience in a pharmaceutical or clinical research setting as a programmer (see separately provided Job Description for further information).
2. Proficient knowledge of clinical trials and drug development processes, industry standards, and statistical concepts used in analysis and submissions of clinical trial data.

Essential Duties & Responsibilities

1. Primarily works at the study, product, or program level.
2. Provides comprehensive programming support, including development of programs, ADaM specifications, and analysis datasets/TLFs while complying with regulatory requirements, departmental SOPs, and work practices.
3. Manages and delivers assignments with quality and within timelines.
4. Provides programming support to CDISC-based e-submissions. Develops, debugs, and enhances SAS programs to support quality control of safety or efficacy derived datasets and TLFs.
5. Implements programming standards and complies with regulatory requirements among project team members and across all projects; communicates project status and resource gaps to management.
6. Responsible for standardization of GSD deliverables (TLGs, Datasets) across study projects within an indication/therapeutic area. Provides input on opportunities for process improvement.
7. Proactively communicates issues impacting programming deliverables with Statistics or Data Management team members.

Education Required

• Bachelor's Degree or Master's Degree in Science, Statistics, Information Technology, or an equivalent combination of education and related work experience.

Experience Required

• Bachelor's Degree + 5 years OR Master's Degree + 4 years of professional experience in a pharmaceutical or clinical research setting as a programmer.
• Proficient knowledge of clinical trials and drug development processes, industry standards, and statistical concepts used in analysis and submissions of clinical trial data.
• Strong understanding of SDTM, ADaM standards, and implementation guides.
• Demonstrated proficiency using SAS to produce:
  • Analysis datasets
  • TLFs
  • eSUB components
• Experience using software applications such as:
  • Pinnacle 21
  • XML
  • MS Office
• Demonstrated ability to work independently and within a team environment.

Experience Preferred / Specialized Knowledge
Functional Knowledge

• Expert-level programming skills and problem-solving ability in SAS.
• Expert-level knowledge in CDISC-based e-submissions, including:
  • Creation of ADaM datasets
  • Associated TLGs in study/project environments (e.g., ISS/ISE)
  • Creation of Bioresearch Monitoring (BIMO) inspections
• Solid knowledge of statistical models used for efficacy data analysis.

Company / Industry Related Knowledge

• Advanced knowledge of government regulations such as:
  • CDISC
  • ICH
• Knowledge related to drug development across multiple therapeutic areas.

Job-Specific Competencies

1. Tackles difficult problems, identifies solutions, and recommends actions to management.
2. Influences communication toward common understanding and actionable results.
3. Strong oral and written communication skills.