CPC is an academically led clinical research organization who has responded to the demands of a fast-paced clinical research industry and competitive market for over 25 years.
CPC offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. These individuals are on the cutting edge of scientific, clinical and regulatory developments. Many of CPC’s leadership team have chaired and/or served on FDA advisory committees including the Cardiovascular and Renal, Endocrine and Metabolism, and Reproductive Health committees.
CPC is known for its collaborative approach with sponsors, sites, and vendors providing superior communication and seamless clinical trial management. We are looking for a Part Time or Full Time Senior Biostatistician to join our team!
SENIOR BIOSTATISTICIAN | AURORA, CO
The Senior Biostatistician is a core member of the Biostatistics & Statistical Programming group who is able to lead teams, provide sound statistical guidance and consultation on both academic and regulatory directed initiatives.
In this position you will:
- Guide project teams in study design and statistical analysis as well as communicate and confidently interact with project team members and clients.
- Provide statistical input on clinical electronic data capture (EDC) design and edit checks.
- Provide statistical leadership for the design, writing and review of study protocols, including the design of studies and sample size/power estimations.
- Lead the development and review of statistical analysis plans (SAP)
- Utilize SAS for programming, validation, analysis, and reporting of clinical data (proficiency in other statistical or programming languages e.g. R, Python is welcome).
- Analyze data for, and prepare and review interim study reports, manuscripts, abstracts, and grants.
- Provide general statistical support and consulting services.
- Ensure compliance with GCP, FDA, and ICH guidelines and CPC standards.
- Effectively communicate statistical issues to project team members to influence team decisions.
Here’s what you will need to bring to the table:
- Master’s or Ph.D. degree in biostatistics or related field
- Minimum of 5 years of experience in the analysis of data for clinical trials
- Ability to work with minimal supervision
- Demonstrable programming experience with SAS 9.0 or higher in a Windows environment
- Ability to work as a member of a team
- Strong communication skills as you may oversee others in the development or validation of statistical programming
- Experience with MS Office Suite (Word, Excel, PowerPoint, Outlook)
- Good knowledge of ICH guidelines, experience with Phase I-III clinical trials and FDA/NDA submissions
- Impeccable attention to detail
- Excellent analytical and organizational skills
- Leadership ability to serve as a lead biostatistician on project teams
Note: Viable applicants will be required to demonstrate their computer skills as well as pass a background check.
This is not a remote position; employee will work the majority of time in the office in a team environment.
CPC offers a comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
- In house exercise room
- Relaxation room
- Monthly office events (i.e. sports games, food)
- Flexible work schedules
- In-office masseuse 3x/month
Please include a short cover letter with answers to the following questions:
- Why would you be a good candidate for this position?
- How many years of experience in the analysis of data for clinical trials do you have?
- Any gaps in your employment history? Please explain
- What are your salary expectations?
- Do you have a Master’s or Ph.D. degree in biostatistics or related field?
- Are you authorized to work in the United States?
- Do you now or will you in the future require sponsorship for employment visa status (e.g., H-1B visa status)?