Senior Manager, Biostatistics

Summary

Join Precision Medicine Group as a Biostatistics Lead, responsible for leading biostatistical efforts in projects and studies. Manage employees, develop departmental procedures, and forecast project resources. Responsibilities include writing statistical analysis plans, providing sample size calculations, and programming CDISC datasets. You will also review clinical documents, provide statistical support, and participate in business development. This role requires an MS degree in a relevant field with 6+ years of experience and extensive knowledge of industry standards. Excellent communication, problem-solving, and leadership skills are essential.

Requirements

• MS degree in statistics, biostatistics, mathematics or equivalent with 6+ years relevant industry experience
• Demonstrates 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 most complex statistical methods that apply to Phase I-IV clinical trials

Responsibilities

• Manage employees, including senior level, 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 through a combination of internal and external resources
• Hire, train, and provide development opportunities for Biostatisticians and Statistical Programmers
• Write and/or review statistical analysis plans
• Provide sample size calculations
• Provide randomization schedules and serve as the unblinded statistician
• Program and/or QC CDISC datasets, tables, and figures using SAS
• Provide input to and/or QC clinical documents, including CRFs, protocols and CSRs
• Provide oversight for assigned projects
• Perform the senior level review on a final analysis package delivery of outputs
• Provide statistical consultative support
• Assist in creation/review of forms and templates
• Participate in business development activities
• Assist other functional areas as needed

Preferred Qualifications

• Experience with oncology and rare disease
• Experience with submissions
• Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines
• Excellent communication and interpersonal skills to effectively interface with others
• Excellent problem-solving skills
• Excellent presentation skills
• Sound judgment/decision making
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients
• Ability to lead and inspire excellence within a team
• Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency
• Results oriented, accountable, motivated, and flexible