Back to jobs
New

Senior/Principal Statistician Consultant - Phase III Oncology (Remote)

United States

 

ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Senior/ Principal Statistician to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes.

 

We are seeking an experienced Senior/Principal Biostatistician with strong hands-on experience supporting Phase III oncology clinical trials. The ideal candidate will have a solid understanding of oncology study design and statistical methodology, strong SAS skills, and the ability to work independently across multiple concurrent studies.

This role will collaborate closely with Statistical Programming and cross-functional teams to support study deliverables, including TFLs, ADaM specifications, interim analyses, and regulatory submissions.

Key Responsibilities

  • Provide statistical expertise and hands-on support for Phase III oncology clinical trials.
  • Contribute to study design, statistical analysis, interpretation of results, and clinical study deliverables.
  • Demonstrate a strong understanding of key oncology endpoints, including:
    • Overall Survival (OS)
    • Progression-Free Survival (PFS)
    • Objective Response Rate (ORR)
    • Duration of Response (DoR)
  • Apply appropriate methods for censoring and time-to-event analyses.
  • Apply and interpret statistical methodologies including:
    • Kaplan-Meier analysis
    • Cox Proportional Hazards models
    • Stratified log-rank tests
  • Author, review, and provide input into TFL and ADaM specifications in close collaboration with Statistical Programming.
  • Review statistical programming outputs, identify discrepancies, and work collaboratively with programmers to resolve issues.
  • Use SAS to independently review outputs and perform data and analysis checks.
  • Manage deliverables across multiple concurrent clinical studies, ensuring timelines and quality expectations are met.
  • Work independently with minimal supervision and quickly become familiar with study requirements, datasets, and programming outputs.
  • Collaborate with Biostatistics, Statistical Programming, Data Management, Clinical, Regulatory, and other cross-functional teams as required.
  • Support interim analyses and Independent Data Monitoring Committee (IDMC/DMC) activities, including preparation and review of DMC outputs.

Required Qualifications

  • Advanced degree (MS, PhD, or equivalent) in Statistics, Biostatistics, or a related quantitative field.
  • Direct hands-on experience supporting at least one Phase III oncology clinical trial.
  • Strong understanding of oncology clinical trial endpoints, including OS, PFS, ORR, and DoR.
  • Strong knowledge of censoring rules and time-to-event analysis.
  • Hands-on experience with Kaplan-Meier, Cox Proportional Hazards, and stratified log-rank methods.
  • Strong SAS programming skills with the ability to review statistical programming outputs and perform independent checks.
  • Experience authoring or reviewing TFL and ADaM specifications and collaborating closely with Statistical Programming.
  • Strong problem-solving skills with the ability to identify and resolve discrepancies in analysis outputs.
  • Ability to work independently, quickly onboard to new studies, and operate effectively with minimal supervision.
  • Demonstrated ability to manage deliverables across multiple concurrent clinical trials while maintaining quality and timelines.
  • Excellent written and verbal communication skills.

Preferred Qualifications

  • Experience supporting FDA and/or EMA regulatory submissions.
  • Experience with IDMC/DMC activities and interim analyses, including preparation and review of DMC outputs.
  • Experience with R programming is a plus.
  • Experience working in a CRO, pharmaceutical, or biotechnology environment.

Key Competencies

  • Phase III Oncology
  • Time-to-Event Analysis
  • Survival Analysis
  • SAS
  • TFL and ADaM Specifications
  • Statistical Programming Collaboration
  • Clinical Trial Analysis
  • Regulatory Submissions
  • IDMC/DMC Support
  • Multi-Study Project Management
  • Independent/Self-Directed Work

 

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.


#LI-TT1 #LI-Remote #LI-Principal #contract

 

 

 

 

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Education

Select...
Select...
Select...
Select...
Select...
What type of employment are you seeking? *
Select...
Select...

Enter country of residence

Select...
Select...
Select...
Select...
Select...
Select...
Select...
Select...

I certify all information provided in this employment application is true and complete. I understand any false information or omission may disqualify me from further consideration for employment and may result in my dismissal if discovered at a later date. 

I authorize the investigation of any or all statements contained in this application and also authorize any person, school, current employer (except as previously noted), past employers and organizations’ names in this application to provide relevant information and opinions that may be useful in making a hiring decision. I release such persons and organizations from any legal liability in making such statements. 

I understand if I am extended an offer of employment, it may be contingent upon my successfully passing a complete background and reference check. I hereby consent to any or all of these pre-employment test/screen/checks as a condition of employment, if required. I consent to the release of any or all medical information as may be deemed necessary to judge my capability to do the work for which I am applying. 

I UNDERSTAND THIS APPLICATION OR SUBSEQUENT EMPLOYMENT DOES NOT CREATE A CONTRACT OF EMPLOYMENT NOR GUARANTEE EMPLOYMENT FOR ANY DEFINITE PERIOD OF TIME. IF EMPLOYED, I UNDERSTAND THAT I HAVE BEEN HIRED AT THE WILL OF THE EMPLOYER AND MY EMPLOYMENT MAY BE TERMINATED AT ANY TIME WITH OR WITHOUT CAUSE AND WITH OR WITHOUT NOTICE. 

Select...
Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in ClinChoice’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...