Manager, Biostatistician (Woodcliff Lake, NJ)
- Work with the clinical study team on study design, development and/or review of clinical study protocols
-Contribute to clinical trial design, protocol concept sheet and protocol development
-Participate study related activities and provide statistical support such as reviewing Case Report Form (CRF) and guidance, validating randomization scheme and developing Study Quality Surveillance Plan (SQS), reviewing Independent Radiology Review Committee Charter and data transfer plan, etc.
-Develop and/or review statistical documents and deliverables for clinical trials including Statistical Analysis Plan (SAP) for individual studies and integrated summaries of drug efficacy and safety, Table, Listing and Graph (TLG) shells, statistical validation plan, Data Set Specification (Rule Book), Data Monitoring Committee Charter and interim analysis plan, Clinical Study Report (CSR) and others
-Work with 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 programming activities, perform QA checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of deliverables
-MS in Biostatistics/Statistics with at least 5 years of experience or a PhD in Biostatistics/ Statistics with at least 4 years of experience in the pharmaceutical, CRO or biotech industry
-Strong SAS programming skills
- Oncology experience is required.
-Familiarity with oncology clinical trial Phase I-III design and survival analysis, submission experience will be plus
Type: Long-term Contract