Senior Manager, Biostatistics - Remote

Overview

Responsible for leading the biostatistics efforts for specific projects and studies, including reviewing statistical sections of protocols, writing statistical analysis plans, and developing SAS programs. In addition, responsible for managing resources within the Biostatistics and Statistical Programming department. As part of the Biostatistics team, this person will also provide technical expertise to the development of programming standards and procedures.

In Short

• Manage employees within the Biostatistics and Statistical Programming functional areas.
• Assist with development and maintenance of departmental procedures and standards.
• Assist with project forecasting and resourcing needs.
• Hire, train, and provide development opportunities for Biostatisticians and Statistical Programmers.
• Write and/or review statistical analysis plans.
• Provide sample size calculations and randomization schedules.
• Program and/or QC CDISC datasets, tables, and figures using SAS.
• Provide oversight for assigned projects and perform senior level reviews.
• Provide statistical consultative support.
• Assist in creation/review of forms and templates.

Requirements

• MS degree in statistics, biostatistics, mathematics or equivalent with 6+ years relevant industry experience.
• Extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
• Experience with SAS.
• Familiarity with complex statistical methods for Phase I-IV clinical trials.

Benefits

• Eligible for a discretionary annual bonus.
• Health insurance, retirement savings benefits, life insurance, and disability benefits.
• Parental leave and paid time off for sick leave and vacation.