
Data Scientist Specialist
2 days ago
The Senior Statistical Programmer is responsible for leading statistical programming support for multiple clinical projects using SAS. This role involves providing expert consultation across the company.
- Deliver key regulatory-compliant output
- Develop programming documentation
- Write efficient code
- Stay updated on programming techniques
- Mentor staff
This position requires a high level of expertise in statistical programming with SAS (Base and Macros). The successful candidate will provide lead statistical programming support for multiple clinical research study projects or study teams.
- Provide statistical programming support for multiple clinical research study projects or study teams
- Develop statistical programming with SAS and provide expert consultation to projects across the company including statistical programming methodology
- Ensure sound methodologies are adopted by establishing proficiency of programming techniques required for clinical trials research which involve either CDISC standards and analysis data sets or production of standard and custom tables listings and figures
- Provide key deliverables based on established proficiency of regulatory requirements for clinical research E-submissions and/or study requirements for Sponsor, Regulatory, Investigator or Safety review meetings
- Develop programming documentation and annotations including specifications, review of mock shells, adhering to relevant Standard Operating Procedures and may contribute to standardization efforts
- Write well-documented, efficient, and high-quality code, conduct code review, supports cross-functional programming activities, and programming validation as needed
- Presents statistical programming topics internally and may present at external conferences
To be successful in this role, you will need a Bachelor's degree plus 4 years of experience as a CDISC/TLF Statistical programmer in a Pharmaceutical/CRO environment. Education in a scientific discipline is preferred.
- Bachelor's degree plus 4 years of experience as a CDISC/TLF Statistical programmer in a Pharmaceutical/CRO environment, education in a scientific discipline preferred
- Understanding of GCP principles and other regulatory standards (e.g. FDA, EMA, and ICH guidance and recommendations) in Clinical Research
- Good analytical skills with the ability to process scientific and medical data
- Strong statistical programming skills in SAS, familiarity with R, Python or other relevant statistical software considered beneficial
This is an excellent opportunity for a highly skilled statistician to join our team and make a significant impact in the development of new treatments and therapies.
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