Bachelor's or master's degree in a relevant scientific discipline or equivalent experience.
5+ years of statistical programming experience in pharma, biotech, or CRO, ideally with CNS trials.
Proven experience leading programming efforts for clinical trials and dataset development.
Advanced SAS proficiency, with hands-on experience with CDISC SDTM and ADaM standards.
Valuable experience in R or Python for data manipulation and reporting (not required).
Familiarity with regulatory submissions and standards, including Pinnacle 21.
Excellent written and verbal communication, with the ability to explain technical concepts to non-experts.
Responsibilities
Lead the development and documentation of CDISC-compliant SDTM and ADaM datasets for CNS trials.
Program and QC tables, listings, and figures for clinical study reports and regulatory submissions.
Interpret protocols and data standards to create analysis-ready datasets.
Act as the primary programming contact for assigned studies, collaborating with cross-functional teams.
Conduct independent QC and peer reviews to ensure accuracy and compliance.
Maintain programming specifications, documentation, and macros to improve efficiency.
Support regulatory submission readiness, including creation of define.xml and response to queries.
Benefits
Fully remote work environment, offering flexibility in work hours and location.
Opportunity for professional growth through mentoring and contributions to process improvements.
Access to collaborative and supportive team culture in a growing organization.
Exposure to diverse programming tasks across multiple projects.
Participation in initiatives that enhance quality and embrace best practices in statistical programming.
Full 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.
ct 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.
dvanced 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.
ble to manage multi-tasks and priorities in a fast-paced, dynamic environment with shifting timelines and evolving sponsor needs.
ble to make complex programming and data-related decisions independently.
ble 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
