Job Description
Responsibilities: - Lead the development, validation, and documentation of CDISC-compliant SDTM and ADaM datasets for CNS clinical trials, ensuring traceability from raw data through analysis outputs.
- Program and QC tables, listings, and figures (TLFs) for interim and final clinical study reports, regulatory submissions, and client deliverables.
- Interpret study protocols, SAPs, and data standards to translate clinical objectives into analysis-ready datasets and outputs.
- Act as primary programming contact for assigned studies, collaborating closely with statisticians, data managers, and medical writers in a fully remote, fast-paced environment.
- Conduct independent QC and peer review of programming deliverables, ensuring accuracy, compliance, and reproducibility of results.
- Develop and maintain study-specific programming specifications, documentation, and macros to streamline programming efficiency.
- Support regulatory submission readiness, including define.xml, reviewer's guides, and response to agency questions.
- Proactively identify and resolve data or programming issues that may impact timelines or analysis accuracy.
- Mentor and support junior programmers, fostering quality, consistency, and CDISC best practices across projects.
- Contribute to process improvement initiatives and template development for a growing statistical programming team.
Requirements:
- Bachelor's or master's degree in Statistics, Biostatistics, Computer Science, Mathematics, or a related scientific discipline; or a combination of education, training and experience to effectively perform the job functions.
- 5+ years of statistical programming experience within the pharmaceutical, biotech, or CRO industry, preferably with prior experience in CNS trials.
- Experience leading programming efforts for clinical trials, including dataset development, TLF production, and QC oversight.
- Advanced proficiency in SAS, with hands-on experience using CDISC SDTM and ADaM standards.
- Experience with R or Python for data manipulation, automation, or reporting is highly valued, though not required.
- Experience with regulatory submissions and standards, including Pinnacle 21, define.xml, and reviewer's guides.
- Experience working in a remote, team-based environment and comfortable with virtual collaboration tools.
- Excellent written and verbal communication skills, and able to explain technical concepts to non-programmers and cross-functional stakeholders.
- Strong interpersonal and teamwork skills, with a collaborative mindset and the ability to work independently and prioritize across multiple projects.
- High attention to detail, with a focus on quality, reproducibility, and traceability in all deliverables (analysis datasets and output).
- Demonstrated ability to follow standard operating procedures (SOPs), adhere to project timelines, and contribute to continuous improvement of programming processes.
- Proactive problem-solver and critical thinker with a willingness to adapt and thrive in a growing, fast-paced CRO environment.
- Able to manage multi-tasks and priorities in a fast-paced, dynamic environment with shifting timelines and evolving sponsor needs.
- Able to make complex programming and data-related decisions independently.
- Able to anticipate analytical needs, understand downstream impacts of programming decisions, and proactively identify gaps in data and specifications
- Comfortable working across functional teams (e.g., clinical, data management, biostatistics, medical writing) and shifting between strategic and tactical tasks quickly.
- Must demonstrate flexibility and adaptability - able to pivot between tasks, troubleshoot issues efficiently, and take initiative in a small, collaborative team setting.
Job Tags
Interim role, Remote work, Shift work,