Position Summary:
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.
Essential functions of the job include but are not limited to:
- 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
Qualifications:
Minimum Required:
MS degree in statistics, biostatistics, mathematics or equivalent with 6+ years relevant industry experience
Other Required:
- 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
Preferred:
- Experience with oncology and rare disease
- Experience with submissions
Skills:
- 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
Competencies:
- 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
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