The Senior Statistical Programmer provides advanced technical expertise to plan, coordinate, and execute programming deliverables across all phases of clinical studies. This role is responsible for developing high-quality datasets and producing Tables, Listings, and Figures (TLFs) in accordance with project specifications and regulatory standards. The Senior Statistical Programmer leads the implementation of integrated programming solutions and ensures rigorous quality control throughout the project lifecycle. In addition to hands-on programming, this position contributes to departmental leadership by providing guidance, mentorship, and technical oversight. The role involves close collaboration with cross-functional teams including clinical operations, data management, biostatistics, and external clients or partners to support timely and accurate delivery of analysis results.
DEGREE & EXPERIENCE, KNOWLEDGE & SKILLS
- 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
Join us in pushing the boundaries of technology through innovative programming solutions!
Job Type: Full-time
Pay: $125,000.00 - $150,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Referral program
- Vision insurance
Schedule:
Work Location: Remot
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