Principal Biostatistician - Oncology

November 8

Apply Now

Receive Emails with Similar Jobs

pfm medical, inc.

WebsiteLinkedInAll Job Openings

Medical Device Manufacturing

11 - 50

Description

• Provides statistical support for all phases of clinical development. • Generate and/or verify randomization schedules. • Develop and review statistical methods of the clinical study protocol including complex study designs. • Provide and/or verify sample size calculations. Perform or assist with advanced calculations including adaptive design. • Provide input into development of case report forms (CRFs). • Author statistical analysis plans, including development of table, figure and listing shells, complex study design and late phase. • Review statistical analysis plans written by other biostatisticians. • Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS. • Perform quality control for statistical based SAS programs and other study documents (e.g., presentations and reports). • Provide or supervise programming and statistical support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests. • Ability to serve as a biostatistical consultant to company staff globally, with understanding of varying regional perspectives. • Review output across programs to ensure consistency. • Provide statistical analysis and reports to Data Monitoring Committees (DMCs) as the unblinded biostatistician. • Review statistical sections of clinical study reports. • Work directly with sponsors, project managers, and external vendors on statistics-related project components. • Interact directly with study team. • Interact directly with sponsors. • Lead all statistical activities for study within timelines. • Independently perform budget health review on projects and review monthly invoices. • Perform oversight responsibilities on projects for other biostatisticians. • Assist with budget development and present at bid defense meetings. • Participate in the development and maintenance of departmental procedures and standards (templates, SOPs, WIs etc.). • Review study tasks to ensure study being conducted in line with agreed budget; identify change in scope. • Other duties as assigned.

Requirements

• Master's degree or equivalent in Statistics, Biostatistics, or related field with 10+ years experience; PhD degree in Statistics, Biostatistics, or related field with 7+ years experience • Experience with SAS • Knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines • Broad knowledge and superior understanding of advanced statistical concepts and techniques

Benefits

• Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation • Discretionary annual bonus