Principal Biostatistician - Fully Remote

CyberCoders Remote
remote regulatory analysis medical data regulatory submissions email r&d health clinical affairs design database writes
November 12, 2022
Houston, Texas
If you are a Principal Biostatistician with experience, please read on!

We are a publicly traded company on the Nasdaq, founded in 1985, as a global medical technology company whose purpose is to enable healthier lives everywhere and every day. We develop groundbreaking products and services that benefit everyone, especially passionate about those that advance women's health and well-being. This allows us to be a company that prospers, grows and empowers women to experience healthier lives.

We are looking for an experienced, independent working Principal Biostatistician to join our R&D department that will be responsible for designing, monitoring, and analyzing our clinical trial data for obtaining FDA clearance or approval of our medical devices.

What You Will Be Doing
  • Assist with solving statistical problems for R&D, QA, QC and Marketing and Manufacturing
  • Provides biostatistical expertise to Clinical Affairs staff; determines appropriate statistical methods and procedures
  • Primary contributor to FDA (and other regulatory) interactions regarding experimental design and statistical analysis.
  • Works with other project team members in Clinical Affairs to ensure CRF and database design meets analysis needs
  • Writes and/or reviews Statistical Analysis Plans (SAPs) and develops and/or reviews table/listing/figure shells for statistical analyses and reports
  • Writes and/or reviews the statistical and data analysis sections of regulatory submissions
  • Develop biostatistical SOPs and work instructions.
What You Need for this Position
  • Clinical Studies/Clinical Trials (either supporting or doing)
  • Data developing protocol
  • Producing SAPs and TLFs for regulatory submissions to FDA
Bonus Points For
  • Statistical Software - SAS or R
  • Regulatory Submissions
  • Medical Device experience
  • Statistical Analysis Plans
Knowledgeable With
  • DA regulatory requirements for IDE, BLA, PMA and 510K submissions
  • CRF and database development
*8 years of experience with a Masters degree or at least 5 years of experience with a Ph.D., in the medical device, biotech, or pharmaceutical industry.*

What's In It for You
  • Competitive Salary
  • Fully Remote
  • Bonus Plan
  • Health/Dental/Vision Coverage
  • 401k Plan
  • Employee Assistance Program
  • Tuition Reimbursement Program
So, if you are a Principal Biostatistician with experience, please apply today!

Colorado employees will receive paid sick leave. For additional information about available benefits, please contact Cameron Chadwick

Email Your Resume In Word To

Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, but you may also:

[email protected]
  • Please do NOT change the email subject line in any way. You must keep the JobID: linkedin : CC24-1708527 -- in the email subject line for your application to be considered.***
Cameron Chadwick - Recruiter - CyberCoders

Applicants must be authorized to work in the U.S.

CyberCoders, Inc is proud to be an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.

Your Right to Work - In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

CyberCoders will consider for Employment in the City of Los Angeles qualified Applicants with Criminal Histories in a manner consistent with the requirements of the Los Angeles Fair Chance Initiative for Hiring (Ban the Box) Ordinance.

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