Experienced SAS Programmer (Contractor/Clinical Research) – Virtual/Top $$
Our client, a NC-based pharmaceutical company developing therapies for oncology and other life-threatening diseases, has an immediate need for 2 statistical programmers to join its R&D team.
Key things to note:
- These are one-year contracts (to start); Pay will be generous
- These can be worked remotely; company is open to candidates throughout the US
- These are Phase II and III oncology studies; Related experience will be important
- The Statistical Programmer may oversee work outsourced to CROs. We seek a strong collaborator. Experience working for sponsor is preferred.
Position will involve applying statistical programming expertise to implement and quality control analyses and reports of data from clinical studies. Deliver statistical programming support for regulatory submissions.
Responsibilities will include:
- Develops and validates statistical programs to analyze and report data from clinical studies.
- Develops statistical programs for the creation of standard tabulation and analysis data sets and creates corresponding supporting documentation.
- Reviews the quality of tables, figures, listings, and data sets.
- Develops table, figure, listing, and data set specifications.
- Critically reviews essential documents, including but not limited to protocols, statistical analysis plans, shell documents, statistical specifications, external data transfer plans, data management plans, and case report forms.
- Critically evaluates collected data and communicates findings with data management and/or external providers.
- Acts as lead statistical programmer for several clinical trials within a project or across multiple projects.
- Oversees statistical programming activities performed by Clinical Research Organizations (CRO) as needed.
- Contributes to the development of relevant procedures and processes to ensure that statistical programs are properly documented and validated according to industry and regulatory standards.
- Supports the preparation of clinical study reports, integrated reports, safety reports, manuscripts, and other documents as required.
Targeted candidate will offer a BS (or higher) degree and 5+ years of programming experience in clinical development. Exceptional SAS programming skills assumed and important.
Other priorities include:
- Superior expertise in the implementation and delivery of industry submission data standards (e.g., SDTM, ADaM, define.xml, reviewer’s guides, bioresearch monitoring support).
- Demonstrated ability to efficiently translate protocols, statistical analysis plans, and collected data into high-quality and meaningful analyses and reports.
- Working knowledge of the International Conference on Harmonization (ICH) guidelines and an understanding of the regulatory and submission requirements from US and global health authorities.
- Working knowledge of statistical design and methodology.
- Experience in analysis and reporting for translational and confirmatory oncology clinical trials preferred.
- Experience overseeing work performed by CROs or other vendors
Finally, this is an emerging business setting in which policies and practices are continually revised and enhanced. We seek a builder who will work well in this dynamic and empowered setting.
This is an immediate need. Please forward resume or CV for prompt consideration.