Associate Director, Biostatistics
Precision for Medicine is a precision medicine CRO.
Our uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical authorities, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology.
We invite you to learn more about our growing organization serving our clients that are researching groundbreaking cancer therapies.
We strive to ensure employees feel appreciated for the contributions they make every single day.
Associate Director is 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.
This position is office based for candidates that are located in the Carlsbad, CA area.
Candidates that are located elsewhere but are on the Pacific Time Zone can work remotely.
- Essential functions of the job include but are not limited to
- Manage biostatistician and/or statistical programmer employees, including senior-level, within the Biostatistics functional area
- 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
- Minimum of 7 years of 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 diseases
- Experience with submissions