Pharmaceutical Company.

Work closely with clinicians, programmers, 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. 

• 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 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. 

• Oversee CRO programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, ensure the quality of CRO deliverables. 

• May work with the Health Outcome team on the design/analysis/validation of projects. 

• May work on submission teams as a statistician and/or a programmer. 

QUALIFICATIONS NEEDED: 

• Must have a MS in Biostatistics/Statistics with at least 5 years of experience or a PhD in Biostatistics/ Statistics with at least 3 years of experience in the pharmaceutical, CRO or biotech industry. 

• Strong SAS programming skills. 

• Oncology experience is required (min 1 year) 

• Good technical writing skills. 

• Good communication skills (verbal and written). 

• Strong teamwork ability/commitment and individual initiative. 

• Strong organizational skills with ability to effectively manage multiple projects.

• Must have a MS in Biostatistics/Statistics with at least 5 years of experience or a PhD in Biostatistics/ Statistics with at least 3 years of experience in the pharmaceutical, CRO or biotech industry.