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.
1. 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.
2. 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.
3. 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.
4. Working independently to accomplish tasks and goals defined by supervisor. Bringing in new ideas to improve the programming process.
Qualifications and education required:
clinical trials in a pharmaceutical/CRO environment. FDA submission experience preferred.
environment or demonstrated leadership in a clinical pharmaceutical/CRO environment.
Skills and aptitude required:
Job Type: Contract
Salary: $75.00 to $90.00 /hour