Senior Statistical Programmer/Analyst Consultant- Oncology (require -BLA Submission and Macro)

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 Senior 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.

Job Summary

We are seeking an experienced Senior Statistical Programmer to provide Phase III study support for BLA submissions. The ideal candidate will have strong hands-on experience with SAS programming, including advanced macro development, and will work closely with biostatistics and clinical teams in a sponsor-dedicated (FSP) environment.

Key Responsibilities

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Perform end-to-end SAS programming for Phase III clinical trials

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Develop and validate SDTM, ADaM datasets, TLFs in compliance with CDISC standards

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Support BLA submissions, including regulatory-ready deliverables

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Design, develop, and maintain complex SAS macros to improve efficiency and standardization

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Collaborate closely with biostatisticians, data management, and cross-functional teams

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Ensure programming deliverables meet quality, timelines, and regulatory expectations

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Participate in programming reviews, QC activities, and issue resolution

Required Qualifications

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Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, or a related field

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7+ years of experience in statistical programming within the pharmaceutical or CRO environment.

• Require Immunology or Immunotherapy TA.

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Strong experience supporting Phase III studies and BLA submissions

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Advanced proficiency in SAS programming, including macro development

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Solid understanding of CDISC standards (SDTM, ADaM)

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Experience working in an FSP or sponsor-dedicated model is highly preferred

Nice to Have

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Oncology is a plus

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Experience working directly with sponsor teams

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Exposure to regulatory interactions and submission timelines

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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