Sr. Statistical Programmer
Sr. Statistical Programmer
Posted on :
27-06-2025
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1 Vacancy
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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 reviewers 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.
- Bachelors or masters 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 and reviewers 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.
Employment Type
Full Time
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