Senior Biostatistician

CPC Clinical Research Located in: Aurora,  Colorado
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CPC Clinical Research Biotechnology Jobs Pharmaceutical Careers
 

JOB DESCRIPTION

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.

CRITICAL REQUIREMENTS

  • 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 with at least 3 years experience with Phase 1-4 clinical trials in the pharmaceutical industry
    • Proven ability to develop Statistical Analysis Plans for clinical trials intended for submission to regulatory agencies
    • Proven ability to contribute to clinical study reports intended for submission to regulatory agencies
    • Proven leadership ability to serve as a lead biostatistician on project teams
    • 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
    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:  
    • 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?
    • Describe your experience supporting clinical trials for the pharmaceutical industry and your ability to lead statistical and programming teams.
    • 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)?
    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/                                                                                                                                       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.

COMPANY INFORMATION

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.

JOB INFORMATION

Seniority Level:
Experienced - Not Management
Function:
  Clinical Research / Affairs
Preferred Industry Background:
  Pharmaceuticals,  CRO / Outsourced Services,  Biotechnology
Managing a team of:
N/A
Required Travel:
Not at all

Base Salary:
Confidential
Bonus:
Benefits:
CPC offers a comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.) In
Other Compensation:
Education Required:
Any
Therapeutic Experience:
Cardiovascular