Senior Statistical Programmer
- Experience Level
- Experienced (non-manager)
Albion Rye Associates are working in partnership with our client, an incredibly well-established and respected full-service CRO who has been supporting the Pharmaceutical industry for 25 years.
Through continued business growth and client requirements, there is some exciting growth within their Statistical Programming team and we would love to speak with you about this.
This is going to be a Senior Statistical Programmer position. Where you will be the programming team lead, the primary point of contact for the sponsor and cross-functional teams, and contribute to the department’s initiative. Providing guidance, mentoring, and training for team members, and help solve issues from cross-functional teams. As well as review draft and final production deliverables to ensure quality and consistency for the projects.
Responsibilities and skills include, however not limited to:
- Actively communicate with Biostatisticians for statistical input and analysis interpretation.
- Follow and reinforce regulatory agency requirements during day-to-day tasks.
- Analyze information and develop innovative solutions to programming and data analysis challenges.
- Annotate CSR following FDA/CDISC or sponsor guidelines.
- Develop CDISC, SDTM, and ADaM specifications and generate SDTM and ADaM datasets using SAS based on the Statistical Analysis Plan.
- Develop TLGs, Patient Profile in support of the CSR, Posters, Manuscripts.
- Develop ADaM data, TLFs for ISS and ISE.
- Create e-submission packages to FDA, following FDA guidelines with no supervision.
- BA/MS degree in Statistics, Mathematics, Computer Science or related scientific disciplines
- At least 3 years of statistical programming experience
- Knowledge and training in high-level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB, and SQL. Database programming experience is a plus.
- In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology.
- Good understanding of the clinical drug development process.
- Strong communication skills and coordination skills. ability to communicate with global teams with supervision.
Whilst this role will be ideal for someone in Philadelphia, PA and the East Coast, remote working is also an option if you are anywhere across the United States.
Please get in touch with Erick Semerene, Head of Biometrics Recruitment:
ALL CONVERSATIONS ARE HELD IN THE STRICTEST CONFIDENCE.
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