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Manager, Statistical programming Consultant- Oncology - Remote

Role overview

Summary

This role is for a Manager, Statistical Programming Consultant at ClinChoice, focusing on leading statistical programming activities for oncology clinical trials. You will work closely with cross-functional teams to ensure high-quality deliverables while managing programming teams and adhering to regulatory standards.

Qualifications

  • Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science, or a related discipline.
  • 8+ years of experience in statistical programming within the pharmaceutical, biotechnology, or CRO industry.
  • Prior experience in a managerial, team lead, or programming lead role.
  • Strong hands-on expertise in SAS programming.
  • Extensive experience supporting oncology clinical trials, particularly solid tumor studies.

Responsibilities

  • Lead and oversee statistical programming activities across Phase I, II, and III oncology clinical trials.
  • Manage, mentor, and provide technical guidance to statistical programmers.
  • Oversee the development, validation, and delivery of SDTM and ADaM datasets and Tables, Listings, and Figures (TFLs).
  • Ensure compliance with CDISC standards, FDA/EMA requirements, and applicable regulatory guidelines.

Key facts

  • Remote from: United States
  • Full time
  • Senior (5-10 years)
  • English

Hard skills

Other skills

  • Leadership
  • Team Management
  • Collaboration

About the company

ClinChoice logo

ClinChoice

  • Clinical Research (CRO)
  • Large
  • 1,001–5,000
ClinChoice is a full-service global clinical CRO dedicated to offering high-quality, efficient and flexible solutions to pharmaceutical, biotechnology, medical device, and consumer products clients worldwide. With a 25 year history of success, ClinChoice continues to be The Standard of Excellence for biostatistics, clinical operations, data management, statistical programming, CDISC, regulatory affairs, medical affairs and pharmacovigilance. ClinChoice has established major delivery centers across US, China, Europe, Canada, India, Japan and the Philippines. It has over 4,000 employees globally, with a strong and talented team, and a growing clinical operations presence in seven countries across Asia, North America and Europe.

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Job description

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Manager, Statistical Programmer Consultant to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

We are seeking an experienced Manager, Statistical Programming Consultant with strong expertise in oncology clinical trials, particularly solid tumor studies, to lead and oversee statistical programming activities across clinical development programs.

The ideal candidate will have strong technical expertise in SAS programming, CDISC standards, and regulatory submissions, along with proven experience managing programming teams and delivering high-quality clinical trial outputs.

Key Responsibilities

  • Lead and oversee statistical programming activities across Phase I, II, and III oncology clinical trials.

  • Manage, mentor, and provide technical guidance to statistical programmers.

  • Oversee the development, validation, and delivery of SDTM and ADaM datasets and Tables, Listings, and Figures (TFLs).

  • Ensure accurate implementation of Statistical Analysis Plans (SAPs) and oncology-specific endpoints, including OS, PFS, ORR, and DoR.

  • Provide programming oversight for survival analysis, Kaplan-Meier curves, and RECIST 1.1-based tumor response assessments.

  • Collaborate closely with Biostatistics, Data Management, and other cross-functional teams.

  • Manage project timelines, resource allocation, and programming deliverables.

  • Ensure compliance with CDISC standards, FDA/EMA requirements, and applicable regulatory guidelines.

Required Qualifications

  • Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science, or a related discipline.

  • 8+ years of experience in statistical programming within the pharmaceutical, biotechnology, or CRO industry.

  • Prior experience in a managerial, team lead, or programming lead role.

  • Strong hands-on expertise in SAS programming.

  • Extensive experience supporting oncology clinical trials, particularly solid tumor studies.

  • Strong knowledge of CDISC standards, SDTM, ADaM, and TFL development.

  • Experience with oncology endpoints, survival analysis, and RECIST 1.1.

  • Proven ability to lead programming teams and manage multiple clinical study deliverables.

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.


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