Senior Principal Biostatistician/Senior Manager, Biostatistician - Study Lead (Oncology) - Remote
- Location
- Remote (US)
- Job type
- Full-time
- Level
- Director
- Education
- Master's degree
- Listed
- 31 days ago
Skills & highlights for this role
- SAS programming
- Statistical Analysis Plans
- Analysis Database Specifications
- clinical study reports
- FDA/ICH GCP
Also useful
- Phase II-III trials
- regulatory interaction
- mentoring
Key Responsibilities
- Lead and provide statistical support for clinical studies, primarily within Oncology
- Act as the lead statistician on assigned studies, overseeing statistical strategy and deliverables
- Author and review key statistical documents, including:
- Statistical Analysis Plans (SAPs)
- Analysis Database Specifications (ADS)
- Statistical sections of clinical study reports
- Review and interpret analysis outputs, ensuring accuracy, quality, and regulatory compliance
- Collaborate with cross-functional teams including Clinical, Programming, Data Management, and Regulatory
- Provide guidance and oversight to statistical programmers as needed
- Communicate statistical concepts, results, and risks clearly to both technical and non-technical stakeholders
- Ensure adherence to regulatory standards (FDA, ICH, GCP) and company SOPs
Required Qualifications
- MS or PhD in Statistics, Biostatistics, or a related field
- Strong experience in Oncology studies
- Hands-on experience writing:
- Statistical Analysis Plans (SAPs)
- Analysis Database Specifications
- Reviewing and interpreting analysis results
- SAS programming skills required (hands-on or strong working knowledge)
- Excellent written and verbal communication skills
- Experience working in a CRO and/or pharmaceutical/biotech environment
Preferred Qualifications
- Experience leading Phase II-III clinical trials
- Prior interaction with regulatory agencies
- Experience mentoring junior statisticians or programmers
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.
About ClinChoice
ClinChoice is a global full-service CRO committed to professional growth and a quality-driven "one-team" culture. We are seeking a 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 a highly skilled Principal Statistician to lead statistical activities for clinical trials. This role requires hands-on statistical expertise, strong communication skills, and the ability to independently lead projects while collaborating closely with cross-functional teams.
Join our team
you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!
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 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.
#LI-TT1 #LI-Remote #LI-Principal #Permanent
Equal opportunity and legal notices
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.
From ClinChoice's careers page, first listed on Rolev.ai on October 10, 2026. Rolev.ai is not the employer.
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Common questions
Where is the Senior Principal Biostatistician/Senior Manager, Biostatistician - Study Lead (Oncology) - Remote job at ClinChoice located?
Yes, this Senior Principal Biostatistician/Senior Manager, Biostatistician - Study Lead (Oncology) - Remote opening at ClinChoice is listed as Remote (US). Always check ClinChoice's application page for specific state eligibility or relocation policies.
What qualifications are required for Senior Principal Biostatistician/Senior Manager, Biostatistician - Study Lead (Oncology) - Remote at ClinChoice?
For the Senior Principal Biostatistician/Senior Manager, Biostatistician - Study Lead (Oncology) - Remote role, ClinChoice highlights a master's degree; experience with SAS programming, Statistical Analysis Plans, Analysis Database Specifications, clinical study reports, FDA/ICH GCP. Rolev.ai can score your existing resume against these requirements and show any skill gaps before you apply.
How do I apply for the Senior Principal Biostatistician/Senior Manager, Biostatistician - Study Lead (Oncology) - Remote position at ClinChoice?
This listing links directly to ClinChoice's Greenhouse application page. You can apply directly on ClinChoice's site, or use Rolev.ai to check your resume fit, generate a zero-hallucination tailored resume and cover letter for this posting, and autofill the Greenhouse application form in 1 click with the Rolev.ai Chrome extension. You always review the form and press Submit yourself.