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CPC

Senior Biostatistician

Biostatistics & Programming – Aurora, Colorado
Department Biostatistics & Programming
Employment Type Full-Time
Minimum Experience Experienced

We are looking for a Senior Biostatistician to join our team!

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.

Please include a short cover letter with answers to the following questions:

  1.  Why would you be a good candidate for this position?
  2.  How many years of experience in the analysis of data for clinical trials do you have?
  3.  Any gaps in your employment history? Please explain.
  4.  What are your salary expectations?
  5.  Do you have a Master’s or Ph.D. degree in biostatistics or related field?
  6.  Are you authorized to work in the United States?
  7.  Do you now or will you in the future require sponsorship for employment visa status (e.g.,    H-1B visa status)?

About CPC:

CPC is an academically led clinical research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 25 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more.

CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.

CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. http://www.cpccommunityhealth.org/

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, potlucks, picnics)
  • Flexible work schedules
  • In-office masseuse 3x/month

Visit our web site to learn more about us and values we embrace: www.cpcmed.org

An Equal Opportunity Employer

CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, gender, gender identity, veteran status, marital status, sexual orientation, age, disability, genetic information or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.

 Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team.

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  • Location
    Aurora, Colorado
  • Department
    Biostatistics & Programming
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced
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