About
Agios Pharmaceuticals
Job Description
Principal, Statistical Programmer
Agios (agios.com) is a biopharmaceutical company committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic diseases. We are growing rapidly with an active research and discovery pipeline across both therapeutic areas. Agios has two approved oncology precision medicines and multiple first-in-class investigational therapies in clinical and/or preclinical development.
The position is responsible for the implementation of assigned Statistical Programming projects and services, with optimal efficiency, through effective leadership, as well as the work performance and technical development of their staff. The position is expected to have expert understanding and experience with SDTM and ADaM development.
Key Responsibilities
* Proven expert experience with SDTM and ADaM developments
* Provides technical and project management leadership in SAS programs and applications designed to analyze and report complex clinical trial data and for electronic submissions of data in CDlSC format
* Provides technical and project management leadership to create, review, and approve documentation required to support data analysis, reporting, and CDlSC data submission
* Provides leadership and project management in cross-functional teams that work on standard operating procedures, guidelines, process improvements, system validation and acquisition, customization, and integration of new tools and technologies
* Regularly works with advanced features of SAS including interfacing ability with other software applications and operating system tools
* Conducts briefings and participates in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMEA, et cetera) for projects with more significant consequences and impact
* Participates on high impact departmental and cross-functional teams working on standard operating procedures, process improvements, system validation, and acquisition, customization, and integration of new tools and technologies
* Displays highly developed organizational leadership qualities
* Performs other duties as assigned
Minimum Requirements
* M.S. (or equivalent degree) and 6+ years of relevant work experience in the life sciences/pharmaceutical industry
* Prior project level programmer experience
* Proven expert in all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
* Exhibits mastery of project management tasks and skills as related to statistical programming including teamwork, planning, organization, delegation, coordination, metrics, and oversight of contractors
* Displays highly evolved written and oral presentation skills that enable him/her to disseminate the importance of complex technical solutions more articulately and persuasively
* Displays highly developed organizational leadership qualities
About Agios Pharmaceuticals
Agios Pharmaceuticals is a biopharmaceutical company discovering and developing therapeutics for cancer metabolism.