Full-Time Senior or Principal Statistical Programmer
Everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” And to find the answers, we connect globally with patients and their families living with the physical and social burdens of severe disease. These connections give us new perspectives, drive our innovation, and offer a hope for a new generation of therapies that will help to transform lives.
To strengthen our Statistical Sciences and Innovation Group, we are looking to fill the position of: Senior or Principal Statistical Programmer.
About the Role
You will be responsible for:
- Leads and supports statistical programming activities for assigned clinical studies, submissions and development initiatives. Coordinates and provides input for assigned project and study teams on timelines and work product required to deliver high quality statistical programming services in close collaboration with CROs.
- Provides a high level of effective collaboration for statistical programming initiatives with key team members within SSI and groups outside of SSI (Clinical Data Operations, Technology and Standards (CDOTS), Global Medical Writing, New Medicines, Global Clinical Project Management, therapy areas, Quantitative Clinical Pharmacology, Marketing & Market Access and Global Clinical Development & Medical Affairs) to facilitate understanding of statistical programming services and work product.
- May program, validate, maintain, and document statistical analysis programs for asset development on the basis of the SAP and of other documents (Protocol, CRF, DMM, ISAP, DAP and ASD) following UCB standard operating procedures and working documents.
- Where applicable, develops innovative programming methodologies (i.e. interactive visualization, dashboards, etc.) to facilitate easier interpretation by customer base
- Ensures that submission and study datasets (SDTM and ADaM), tables, figures, listings, statistical output, and program documentation meet standards requirements of regulatory agencies and other departments within UCB.
- Ensures that datasets, tables, figures, listings, and statistical outputs are produced in an efficient manner, following SSI procedures and standards. Develops specification documentation for datasets (SDTM and ADaM), pooled datasets, tables, figures, listings, and associated metadata.
- Supports direction, motivation, and oversight of statistical programming resources (internal and external) for timely delivery of all statistical programming outputs. Mentors and trains other statistical programmers as needed.
- Ensures compliance with the 21-CFR Part 11 regulations in terms of validation of SAS programs used for statistical reporting of clinical studies.
You should have:
- 3+ (with Master’s degree) to 7+ (with Bachelor’s degree) years in statistical programming within the Biotechnology and/or Pharmaceutical Industry (including clinical research organizations) with proven successful track record in pharmaceutical development.
- Excellent understanding and profound knowledge of statistical programming aspects required for regulatory submissions.
- Expert SAS Software Programming skills, including experience with advanced DATA step, SQL and macro development to solve complex programming tasks and/or expert in other programming languages like R, or Python. Experience in Data Visualization would also be advantageous.
- Advanced clinical studies design and analysis experience.
- Advanced knowledge of statistical principles.
- Good leadership abilities and interpersonal skills to mentor and lead statistical programmers to successfully deliver high quality project, study team statistical programming work product and oversee CRO statistical programming teams.
How to ApplyApplications accepted via career page: https://careers.ucb.com/job/Raleigh-Senior-or-Principal-Statistical-Programmer-Nort/618053701/
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