Sr. Manager/ Manager of Statistical Programming
FibroGen (NASDAQ: FGEN) is seeking to change peoples’ lives by bringing innovative therapies to life. We are motivated, curious, and passionate thinkers who believe in doing something truly important.
Scope of Responsibilities
The Manager/Sr. Manager (title will be based on experience) will be responsible for management of statistical programming activities and study related projects while also developing and implementing SAS programs to efficiently produce analyses. Exercise judgment within generally defined practices and policies in selecting methods and policies.
- ·Participate in CRF design, database review, data management plan, data review, data validation procedures, and review of data listings
- ·Design, develop, implement, and maintain software for the monitoring of ongoing studies, reporting, and analysis of clinical trials
- ·Provide consistency across protocols within a project on CRFs, database design, analyses files, and tables, listings, and graphs
- ·Produce data listings, summary tables and graphics for interim and final analyses and publications
- ·Create statistical files for statistical analysis. Integrate data across studies within a project. Test, document, review and validate all programs according to department guidelines
- ·Provide consulting and systems support for applications software. Develop new applications software and identify key feature set
- ·Coordinate data transfer and/or programming standards with CROs and vendors. Work with minimal supervision
- ·Collaborate with other Biometrics functions for all activities related to analyses of clinical trial data.
- ·Responsible for execution of ad-hoc requests, manuscripts, posters, and presentations.
- ·Act independently to determine methods and procedures on new assignments
- Minimum of 8 years of SAS programming in the pharmaceutical or biotechnology industry with a BA/BS in computer science, statistics, math or MA/MS with 8 years of experience.
- Expertise in SAS programming language (especially data step, and summarization procedures), report generation, and standards for programming and validation
- Experienced in macro writing. Knowledge of advanced statistical procedures in SAS including LIFETEST, MIXED, GLM, especially SAS/GRAPH
- Experience with CDISC data standards required. Knowledge of database and data warehouse theory.Data mining experience is a plus
- Experience as a senior statistical programmer level in a pharmaceutical or CRO working in a FDA regulated environment
- Experience with Clinical Study Reports and NDA submission.
- Understanding of regulatory guidelines that affect statistical deliverable
- Ability to work on multiple tasks simultaneously and meet project deadlines
- Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment
- Communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email