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Sr. Statistical Programmer

Sr. Statistical Programmer

Katalyst Healthcares & Life Sciences

Edison, NJ • Remote

Other

Posted 12 days ago

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.
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About Katalyst Healthcares & Life Sciences

Sourced by ZipRecruiter

Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.

Industry

Scientific research and development services

Company size

51 - 200 Employees

Headquarters location

South Plainfield, NJ, US

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Frequently asked questions

Q: What skills or qualities help someone succeed as a Senior Statistical Programmer?

A: To succeed as a Senior Statistical Programmer, key technical skills include proficiency in programming languages such as R, Python, or SAS, as well as expertise in statistical software like SAS, SPSS, or R Studio. Additionally, strong analytical and problem-solving skills, along with the ability to communicate complex statistical concepts to non-technical stakeholders, are essential. A combination of these technical and soft skills enables Senior Statistical Programmers to effectively design, implement, and interpret statistical models, ultimately driving data-driven decision-making and career growth in the field.

Q: What is the career path for a Senior Statistical Programmer?

A: A Senior Statistical Programmer's career path typically begins with entry-level roles such as Statistical Programmer or Biostatistician, progressing to mid-level positions like Senior Statistical Programmer or Lead Programmer, and eventually reaching senior roles like Principal Statistical Programmer or Director of Biostatistics. Key opportunities for skill development and growth include mastering programming languages like R, SAS, or Python, learning statistical software like SQL or data visualization tools like Tableau, and developing leadership and communication skills to manage teams and collaborate with stakeholders. Long-term career prospects may lead to roles in data science, biometrics, or regulatory affairs, or even transition into leadership positions like Department Head or Director of Data Science.

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Katalyst Healthcares & Life Sciences job posting for a Sr. Statistical Programmer in Edison, NJ with a salary of $108,500 to $150,100 Annually with a map of Edison location.