Junior Statistical Programmer Analyst-FTE

The Junior Statistical Programmer is a delivery-focused role supporting clinical trial programming activities under the guidance and supervision of experienced Statistical Programmers and Programming Team Leaders. The individual will contribute to the development, validation, and maintenance of statistical programming deliverables and gain hands-on experience in clinical trial data and industry standards.

Responsibilities

Programming for Clinical Trials

• Support the development and validation of datasets, tables, figures, and listings for clinical trials.
• Perform programming activities using SAS and/or R under appropriate guidance and review.
• Assist with processing and integrating data from internal and external sources.
• Support ad hoc analyses and programming activities for clinical development and other Research & Development functions.
• Assist with the development, review, and maintenance of programming specifications and documentation.
• Contribute to the development and review of SDTM and ADaM datasets and specifications.
• Support the preparation and review of Define-XML and other clinical trial documentation.
• Work closely with Senior Statistical Programmers, Biostatisticians, Data Managers, and other cross-functional team members.

Electronic Submissions

• Support the programming and validation of CDISC-compliant datasets and deliverables for regulatory submissions.
• Assist with the preparation of supporting documentation for electronic submissions.
• Ensure programming outputs follow applicable standards, specifications, and quality requirements.

Quality and Validation

• Perform programming validation and quality checks according to established procedures.
• Identify, document, and resolve programming issues in collaboration with senior team members.
• Ensure assigned deliverables are completed accurately and within agreed timelines.

Standards and Guidelines

• Follow departmental programming standards, working instructions, and applicable industry guidelines.
• Develop knowledge of CDISC standards, including SDTM and ADaM.
• Assist in maintaining and improving programming macros, utilities, and reusable functions.

Qualification & Experience

• Bachelor's or Master's degree in Computer Science, Statistics, Mathematics, Engineering, Life Sciences, or a related discipline.
• 0–2 years of experience in statistical programming, preferably within the pharmaceutical, biotechnology, CRO, or clinical research industry.
• Basic to intermediate knowledge of SAS and/or R.
• Familiarity with SAS programming and SAS Macro language is preferred.
• Basic understanding of clinical trial data and the drug development process.
• Knowledge or exposure to CDISC standards, SDTM, and ADaM is preferred.
• Familiarity with clinical trial datasets, tables, figures, and listings is an advantage.
• Strong attention to detail and commitment to data quality.
• Ability to work effectively in a team environment and learn from senior team members.
• Ability to manage assigned tasks and meet project timelines.