Summary Of Responsibilities
- Provide Statistical Programming support for clinical trial projects.
- Develop, validate, and maintain SAS programs and outputs for the management, analysis, and reporting of clinical trial data.
- Develop and maintain data transfer programs in accordance with client specifications and project requirements.
- Develop Data Management (DM) SAS listings as per client specifications and study standards.
- Review draft and final production outputs to ensure quality, accuracy, and consistency.
- Take ownership of the quality and integrity of all assigned deliverables.
- Collaborate effectively with cross-functional teams, including Clinical Data Management, Statistical Programming, and other project stakeholders.
- Effectively prioritize and manage multiple studies, tasks, and competing priorities in a fast-paced environment, consistently delivering high-quality results while meeting project timelines and deliverables.
- Demonstrate a positive and professional attitude, contributing to a collaborative and productive team environment.
- Continuously develop technical, industry, and project-related knowledge and skills.
- Maintain a high level of attention to detail and ensure all work is delivered to the highest quality standards.
- Develop strong problem-solving skills and proactively seek guidance from senior Statistical Programming staff when required.
- Gain knowledge of broader Statistical Programming activities and responsibilities under the guidance of senior team members.
- Adhere to Fortrea Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and Quality Management System (QMS) requirements.
- Support process improvement initiatives and contribute to operational excellence within the department.
- Perform additional duties and responsibilities as assigned by senior Statistical Programming staff or management.
Qualifications (Minimum Required)
- Bachelor's degree in computer science, Life Sciences, Mathematics, Statistics, or a related discipline.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Language Skills Required: Speaking: English required Writing/Reading: English required
Experience (Minimum Required)
- 1 to 3 years of SAS programming experience in the CRO or Pharmaceutical Industry, or an equivalent combination of education, with a solid understanding of programming fundamentals and program development principles.
- Mandatory experience in developing and maintaining vendor data programs.
- Experience in coding, database reconciliation, PK deviation analysis, and development of custom listings is advantageous.
- Experience in SAS macro development, debugging, and working with complex macros would be an advantage.
- SAS certification is desirable but not mandatory.
- Understanding of the clinical trial process.
- Ability to work effectively with cross-functional teams and stakeholders.
- Results-driven with a strong focus on delivery and accountability.
- Strong attention to quality and continuous improvement.
Physical Demands/Work Environment
- Office environment (Hybrid)
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