Support the Biostatistics team by carrying out programming activities of statistical programmers and work closely with clinicians, programmers, study team and publication managers to generate and QC outputs; and ensure timely and accurate programming and validation activities for clinical studies and publications. Review abstract/manuscripts (publication) to ensure accuracy, quality and soundness of statistical methodologies, and overseeing external vendors as required.
• Providing statistical programming and validation support for clinical study reports, and publications. 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. Work with the clinical study team on study design, development and/or review of clinical study protocols.
• Develop and/or review statistical analysis plans, including Table/listing/figure shells, and final study report for clinical studies; perform post-hoc statistical analyses as needed. Work 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.
• Work with the project statistician and clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality.
• 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.
• Work independently to accomplish tasks and goals defined by supervisor and bringing in new ideas to improve the programming process and maintaining standards for programming activities.
• Oversee CRO programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of CRO deliverables and may work on submission teams as a statistician and/or a programmer.
Qualifications and Education Required:
• MS in Biostatistics/Statistics preferred, with at least 7 years of experience in the pharmaceutical,
CRO or biotech industry.
• Strong SAS programming skills, with experience in SAS-Base, MACRO, STAT, and GRAPH.
• Strong CDISC data standards, e.g. SDTM and ADaM
• Good technical writing skills.
• Good communication skills with strong verbal, written and interpersonal communication skills.
• Strong organizational skills with ability to effectively manage multiple projects.
• Strong teamwork ability/commitment and individual initiative.
• Proven experience with UNIX and Windows operating systems.
• Understanding of the software development life cycle.
• Understanding of FDA guidelines.
• Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality.
• Applies good judgment and demonstrates initiative to resolve issues.
Source: Job Diva – Job Listing