Principal Biostatistician for inhouse project (Permanent role)

Posted 12 Days Ago
Be an Early Applicant
Hiring Remotely in United States
Remote
Expert/Leader
Pharmaceutical
The Role
Lead statistical strategy and deliverables for clinical trials (primarily immunology), author and review SAPs and ADS, interpret analysis outputs, ensure regulatory compliance, collaborate with clinical, programming, data management and regulatory teams, oversee/mentor statisticians and programmers.
Summary Generated by Built In

 

ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Clinical Project Manager II 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!

Key Responsibilities
  • Lead and provide statistical support for clinical studies, primarily within Immunology or any therapeutic areas

  • 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.

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 #Principal#Permanent

 

 

 

 

 

Skills Required

  • MS or PhD in Statistics, Biostatistics, or a related field
  • Strong experience in Immunology or other therapeutic area clinical studies
  • Experience authoring Statistical Analysis Plans (SAPs)
  • Experience authoring Analysis Database Specifications (ADS)
  • Experience reviewing and interpreting analysis results
  • SAS programming skills (hands-on or strong working knowledge)
  • Excellent written and verbal communication skills
  • Experience working in a CRO and/or pharmaceutical/biotech environment
  • Experience leading Phase II-III clinical trials
  • Prior interaction with regulatory agencies
  • Experience mentoring junior statisticians or programmers

ClinChoice Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ClinChoice and has not been reviewed or approved by ClinChoice.

  • Flexible Benefits Flexible arrangements, including telecommuting and flextime with no core hours in some regions, are highlighted for many roles. Feedback suggests flexibility is commonly available but depends on role and location.
  • Leave & Time Off Breadth Vacation, personal, and sick days are part of the core package, with some markets granting paid leave from the date of hire. Feedback suggests time off is standard-to-decent across locations, though specifics vary.
  • Healthcare Strength Health coverage is positioned as a core benefit, with some accounts describing overall benefits as full or good. In the U.S., healthcare sits within a conventional CRO package alongside medical, dental, and vision.

ClinChoice Insights

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The Company
Horsham, Pennsylvania
5,000 Employees
Year Founded: 1995

What We Do

ClinChoice is a global full-service Contract Research Organization (CRO) specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies, aiming to accelerate the development and commercialization of innovative drugs and devices.

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