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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 and education verification check.

This is not a remote position; team member will work the majority of time in the office in a team environment.

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:

  • Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
  • Matching 401(k) plan
  • 10 paid holidays
  • In-suite exercise room
  • In-suite relaxation room
  • In-office masseuse 3x/month
  • Monthly fun events (i.e. sports games, potlucks, picnics)
  • Flexible work schedules

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, sex, 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
  • Minimum Experience
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