What are the responsibilities and job description for the Senior Statistical Programmer position at NJS Associates Company?
Company Description
NJS Associates Company is a biostatistics-led CRO founded in 2011, delivering regulatory-ready biometrics expertise across Phase I–III clinical development. Specializing in oncology, CNS, cardiovascular, rare diseases, vaccines, and other high-complexity areas, NJS supports biotech and pharmaceutical sponsors with strategic biostatistical and programming solutions. Having contributed to over 100 clinical trials and 10 regulatory submissions, including NDA, BLA, and global filings, NJS provides integrated teams from study design to submission. NJS offers flexible delivery models tailored to sponsor needs, such as CRO delivery, functional service provider (FSP), and strategic biometrics staffing.
Role Description
This is a full-time, hybrid role for a Senior Statistical Programmer based in New Jersey, United States. As a Senior Statistical Programmer, you will be responsible for developing, testing, and validating datasets, analysis outputs, and reports to support clinical trial analysis. You will collaborate closely with biostatisticians and clinical teams to ensure data accuracy and compliance with regulatory standards. The role involves creating submission-ready datasets, managing programming projects, and supporting regulatory submissions and audits.
Qualifications
- Proficiency in programming languages such as SAS, R, and other statistical tools
- Strong understanding of CDISC data standards, including SDTM and ADaM, as well as regulatory requirements for data submission
- Ability to handle multiple projects independently, prioritize tasks, and meet deadlines
- Excellent problem-solving skills with attention to detail
- Master’s or Bachelor’s degree in Biostatistics, Computer Science, or a related field with relevant experience
- 8 years of experience in statistical programming within a clinical trial or pharmaceutical environment
- Strong communication skills and ability to collaborate across multidisciplinary teams
- Knowledge of clinical data, trial design, and regulatory submission processes
- Experience in oncology or other complex therapeutic areas is a plus