Bachelor's or master's degree in Statistics, Biostatistics, Computer Science, Mathematics, or related field; or equivalent experience.
5+ years of statistical programming experience in pharma, biotech, or CRO, ideally with CNS trials.
Proven leadership in programming for clinical trials, particularly in dataset creation and TLF production.
Advanced SAS proficiency and practical experience with CDISC SDTM and ADaM standards.
Familiarity with R or Python for automation and data handling is a plus, though not mandatory.
Experience in regulatory submission processes, including familiarity with definitions and guides.
Strong communication skills to translate technical information to non-programmers.
Responsibilities
Lead the development of CDISC-compliant datasets for CNS clinical trials, ensuring data traceability.
Program and perform QC on tables, listings, and figures for clinical reports and regulatory submissions.
Interpret and translate study protocols into analysis-ready datasets and outputs.
Act as primary programming contact, working collaboratively in a fully remote environment.
Conduct quality checks and peer reviews of programming outputs for accuracy and compliance.
Develop study-specific programming documents and macros to enhance efficiency.
Proactively tackle data/programming issues to maintain project timelines.
Benefits
Fully remote work environment, promoting work-life balance.
Opportunity to mentor junior programmers, enhancing leadership skills.
Engagement in process improvement initiatives within a growing team.
Exposure to a variety of programming tools and practices, fostering skill development.
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
