Senior Statistical Programmer Consultant (Oncology) Remote

Posted 3 Days Ago
Be an Early Applicant
Hiring Remotely in United States
Remote
Senior level
Pharmaceutical
The Role
Lead end-to-end statistical programming for oncology clinical trials: develop and validate SDTM/ADaM datasets, produce TLFs, support integrated analyses (ISS/ISE), manage study timelines and vendors, and prepare submission-ready outputs (define.xml, annotated CRFs, reviewer guides) for regulatory submissions (FDA/EMA/PMDA).
Summary Generated by Built In


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. 

The Senior Statistical Programmer will serve as a senior technical expert responsible for end-to-end programming deliverables, study leadership, and oversight of internal teams and external vendors. This role requires advanced expertise in SAS, familiarity with R, deep knowledge of CDISC standards, and strong experience working on oncology studies and regulatory submissions.

Key ResponsibilitiesTechnical Leadership
  • Lead programming activities for oncology clinical trials across multiple studies.

  • Develop, validate, and maintain SDTM and ADaM datasets following CDISC guidelines.

  • Oversee production of Tables, Listings, and Figures (TLFs) for study reporting and submissions.

  • Provide SAS programming expertise to support complex data derivations and analyses.

  • Review and ensure traceability, consistency, and quality of all programming deliverables.

Project & Study Management
  • Act as programming lead for assigned studies, managing timelines and deliverables.

  • Work closely with Biostatistics, Data Management, Medical Writing, and Regulatory Affairs.

  • Coordinate with CROs and external vendors, ensuring compliance, quality, and adherence to client programming standards.

  • Support integrated analyses including ISS/ISE.

Regulatory & Submission Support
  • Prepare submission-ready programming outputs and documentation, including define.xml, annotated CRFs, and reviewer guides.

  • Ensure all programming meets regulatory requirements (FDA, EMA, PMDA).

  • Contribute to responses for regulatory queries and data requests.

 

 

Required Qualifications
  • Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field.

  • 8–12+ years of statistical programming experience in pharma/biotech or CRO.

  • Expert-level proficiency in SAS.

  • Strong understanding of CDISC SDTM and ADaM standards.

  • Significant experience supporting oncology clinical trials (hematologic or solid tumors).

  • Experience supporting regulatory submissions and preparing submission-ready outputs.

  • Excellent communication skills and ability to collaborate cross-functionally.

 

 

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.

 




Skills Required

  • Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field.
  • 8-12+ years statistical programming experience in pharma/biotech or CRO.
  • Expert-level proficiency in SAS.
  • Familiarity with R.
  • Deep knowledge of CDISC SDTM and ADaM standards.
  • Experience developing and validating SDTM and ADaM datasets.
  • Experience producing Tables, Listings, and Figures (TLFs) and submission-ready outputs (define.xml, annotated CRFs, reviewer guides).
  • Significant experience supporting oncology clinical trials (hematologic or solid tumors).
  • Experience supporting regulatory submissions and responding to regulatory queries (FDA, EMA, PMDA).
  • Excellent communication skills and ability to collaborate cross-functionally; study leadership experience.

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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