Biostatistician

LanceSoft • Woodcliff Lake, NJ, United States • $200k - $250k / year • 2w ago

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

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.

• 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.

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