Vacancy expired!
Kelly Science is looking for great individual to join as Principal Statistical Programmer related to oncology clinical studies. Reporting to Senior Director in Statistics. Will work closely with cross-functional teams on single possibly multiple clinical development programs. Remote - Principal Statistical Programmer, (Remote with some travel for team or client meetings Direct Hire
- Typical requests include internal ad-hoc requests, periodic safety and efficacy updating report, TLF output supporting presentations, publications and health authority submissions.
- The Principal Statistical Programmer for Early Stage will be responsible for providing timely support to the study team on all programming requests, including internal programming deliverables requested by POINT study team and oversight of CRO statistical programming activities.
- Demonstrate extensive understanding of SAS programming concepts and techniques in pharmaceutical/biotechnology setting, independently develop, test, and document SAS programs and macros for programming deliverables. Create, maintain the programming specifications for the data sets, review the programming specifications provided by CRO.
- Create and validate SAS outputs including SDTM and ADaM datasets, and TLFs or ad-hoc output per study team request.
- Responsible for the creation of patient profile and clinical summary report package.
- Understand and perform in accordance with regulatory standards.
- Create and validate SAS outputs supporting presentations, publications and health authority submissions
- MS in mathematics, statistics or related analytic field.
- Minimum 7 years of hands-on statistical programming experience in CRO, biotech, or pharmaceutical setting, including SAS/BASE, SAS/STAT, SAS/GRAPH and SAS Macro languages.
- Open to traveling 10 within North America for team building event Working knowledge in all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of related disciplines, biostatistics, statistical programming and CDM.
- Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define package, reviewer s guide and submission standards.
- Working knowledge GCP/ICH standards, 21 CFR Part 11 and FDA requirements with prior experience filing NDA/MAA/BLA preferred.
- Demonstrates leadership, flexibility, critical thinking, time management and problem-solving skills.
- Ability to work independently, while being a collaborative team member in a dynamic fast-paced and lean environment.
- Motivated learner who is looking to advance own experience.
Vacancy expired!