About the Company: A global Pharmaceutical Company
Benefits: Real Staffing offers medical, dental, vision, 401K, voluntary life insurance, short term/long term disability.
About the Role: To support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors (as required), and to ensure timely and accurate programming and validation activities for clinical studies and publications. Contributes to the overall efficiency and best practice of the Biostatistics group, demonstrating the ability to work efficiently and to a high standard within a clinical team environment.
Your Main Responsibilities:
Providing statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the following areas: SDTM datasets, ADaM datasets, statistical tables, figures, listings,and other internal and external requests (e.g., publications).
Accessing and converting data to SAS from Database management system and PC file formats (e.g., MS Excel, text files).
Working with external vendors in order to develop or monitor the content and structure of SAS data sets.
Working closely with clinicians, statistician, and publication managers to generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality, and soundness of statistical methodologies; coordinate internal resource utilization for publication and generate activities metrics for management review.
Providing input to the Database and CRF Development, creating edit check programs and providing feedback to the Data Management.
Providing input in developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents.
Maintaining standards for programming activities.
Working independently to accomplish tasks and goals defined by supervisor
Bringing in new ideas to improve the programming process.
Requirements
Minimum 10+ years experience in SAS programming for phase I-IV
clinical trials in a pharmaceutical/CRO environment. FDA submission experience preferred.
Some project experience in a pharmaceutical/CRO programming
environment or demonstrated leadership in a clinical pharmaceutical/CRO environment.
Skills and aptitude required:
Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office.
Experience in CDISC data standards, e.g. SDTM and ADaM
Proven experience with Unix and Windows operating systems.
Understanding of the software development life cycle.
Understanding of FDA guidelines.
EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
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