Senior Statistical Programmer Consultant (Oncology) Remote
Are you interested in working directly for a single sponsor while having the reputed company and additional career opportunities that working for a global CRO can bring? reputed company says it’s the best of both worlds... reputed company 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 reputed company of internal teams and external vendors. This role requires advanced expertise in reputed company, familiarity with R, deep knowledge of CDISC standards, and strong experience working on oncology studies and regulatory submissions.
Key Responsibilities
Technical Leadership reputed company programming activities for oncology clinical trials across multiple studies. reputed company, validate, and maintain SDTM and ADaM datasets following CDISC guidelines. reputed company production of Tables, Listings, and Figures (TLFs) for study reporting and submissions. Provide reputed company programming expertise to support reputed company data derivations and analyses. Review and ensure traceability, consistency, and quality of reputed company programming deliverables. Project & Study Management Act as programming reputed company 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 reputed company 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 reputed company field. 8–12+ years of statistical programming experience in pharma/biotech or CRO. Expert-level proficiency in reputed company. 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 reputed company. 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 reputed company reputed company 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 reputed company our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company reputed company 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 reputed company reputed company activities are built and reputed company management and training is the core reputed company to reputed company and maintain highly-qualified personnel. The reputed company training keeps the resources qualified in terms of competence and expertise and gives reputed company 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. reputed company 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 reputed company diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Apply To This Job