ClinChoice Logo

ClinChoice

Principal Biostatistician for inhouse project (Permanent role)

Reposted 13 Days Ago
Be an Early Applicant
Remote
Hiring Remotely in United States
Expert/Leader
Remote
Hiring Remotely in United States
Expert/Leader
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.
The summary above was generated by AI

 

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!

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 #LI-Principal #Permanent

 

 

 

 

 

Similar Jobs

17 Minutes Ago
Remote or Hybrid
United States
112K-140K Annually
Senior level
112K-140K Annually
Senior level
Artificial Intelligence • Consumer Web • Edtech • Enterprise Web • HR Tech • Social Impact • Generative AI
Lead end-to-end 8-12 week onboarding engagements for strategic enterprise customers, configuring the Udemy Business platform, delivering training and integrations (e.g., SSO), mentoring junior consultants, and ensuring smooth handoff to Customer Success while shaping scalable onboarding playbooks and capturing customer insights.
Top Skills: AnalyticsSsoUdemy Business
An Hour Ago
Remote or Hybrid
United States
64K-64K Annually
Junior
64K-64K Annually
Junior
HR Tech • Information Technology • Professional Services • Sales • Software
Prospect and generate new business opportunities through outbound outreach, phone and email engagement, identify decision-makers and buying readiness, manage prospect data, and collaborate with marketing to build the top of the revenue funnel.
Top Skills: Linkedin Sales NavigatorOutreachSalesforceSalesloft
3 Hours Ago
Remote or Hybrid
45K-85K Annually
Junior
45K-85K Annually
Junior
Artificial Intelligence • Fintech • Insurance • Marketing Tech • Software • Analytics
Handle inbound/warm insurance leads, consult customers on Property & Casualty coverage, close sales, and maintain required licensing. Participate in paid remote training, meet schedule and workspace requirements, and achieve sales targets with provided equipment and commission opportunities.
Top Skills: CableDslFiberPcWired High-Speed Internet (100 Mbps Down/20 Mbps Up)

What you need to know about the Seattle Tech Scene

Home to tech titans like Microsoft and Amazon, Seattle punches far above its weight in innovation. But its surrounding mountains, sprinkled with world-famous hiking trails and climbing routes, make the city a destination for outdoorsy types as well. Established as a logging town before shifting to shipbuilding and logistics, the Emerald City is now known for its contributions to aerospace, software, biotech and cloud computing. And its status as a thriving tech ecosystem is attracting out-of-town companies looking to establish new tech and engineering hubs.

Key Facts About Seattle Tech

  • Number of Tech Workers: 287,000; 13% of overall workforce (2024 CompTIA survey)
  • Major Tech Employers: Amazon, Microsoft, Meta, Google
  • Key Industries: Artificial intelligence, cloud computing, software, biotechnology, game development
  • Funding Landscape: $3.1 billion in venture capital funding in 2024 (Pitchbook)
  • Notable Investors: Madrona, Fuse, Tola, Maveron
  • Research Centers and Universities: University of Washington, Seattle University, Seattle Pacific University, Allen Institute for Brain Science, Bill & Melinda Gates Foundation, Seattle Children’s Research Institute

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account