The successful candidate will function as study statistical programmer or lead statistical programmer for an indication and be responsible for study- or drug-program-level statistical programming deliverables including review of CRFs, review of statistical analyses plans, development of programming specifications for analyses data sets and outputs, hands-on statistical programming activities, and review of deliverables from CROs. The successful candidate must have working knowledge of CDISC requirements and Pinnacle-21.
- Provide 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. Accountable for study-level or submission-level statistical programming deliverables on assigned projects, including timeliness and quality of deliverables.
- Review statistical analyses plans and case report forms.
- Develop or validate technical programming specifications and programs to generate analysis datasets using Agios or ADaM standards or study-specific/submission-specific requirements.
- Develop or validate specifications and programs to generate tables, listings, and figures based on Agios standards or study-specific/submission-specific requirements.
- Ensure documentation is maintained to the standard required according to CDISC-compliant submissions and is acceptable for audit.
- Help establish and maintain statistical programming standards at Agios.
- Ensure that all study or indication-level statistical programming activities are conducted in compliance with relevant regulatory requirements, Agios SOPs and Agios standards.
- Serve as a general statistical programming resource at Agios including representation in cross-functional teams working on standard operating procedures, guidelines, process improvements, system validation and acquisition, customization, and integration of new tools and technologies.
- MS or equivalent degree with:
- 7+ years biopharmaceutical industry experience
- 3+ years project management experience as a statistical programmer
- Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment
- Extensive experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate analysis datasets, tables, listings, and figures
- Knowledge of clinical database design, specifically electronic data capture using Inform, Medidata, and Oracle
- Experience supporting electronic submissions in the eCTD format
- Excellent oral and written communication skills