Principal Statistical Programmer Consultant – Oncology, Solid Tumors

ClinChoice

. Lead and oversee statistical programming activities for oncology clinical trials, primarily focused on solid tumor indications .

Posted 11/6/2026contractRemote • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in statistical programming for oncology clinical trials, with a strong focus on SAS programming, CDISC standards, and regulatory submissions. Capable of providing technical leadership and mentorship while collaborating effectively with cross-functional teams.

Highest-signal resume keywords

SAS ProgrammingCDISC SDTM And ADaM StandardsOncology Efficacy EndpointsTechnical LeadershipRegulatory Submissions

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical ProgrammingKaplan-Meier AnalysisCox Proportional Hazards ModelsComplex TFL DevelopmentData ValidationStatistical AnalysisClinical Trial SupportProgramming OversightOncology Data AnalysisRegulatory Compliance

Soft Skills

CommunicationProblem-SolvingCollaborationMentorshipLeadership

Industry Keywords

Oncology Clinical TrialsSolid Tumor IndicationsFDAEMAICH-GCPImmuno-OncologyTargeted Cancer TherapiesPhase I TrialsPhase II TrialsPhase III Trials

About the role

Key responsibilities & impact

Lead and oversee statistical programming activities for oncology clinical trials, primarily focused on solid tumor indications
Develop, validate, and maintain SDTM and ADaM datasets in compliance with CDISC standards
Program and review complex tables, figures, and listings for clinical study reports and regulatory submissions
Support oncology efficacy and safety analyses, including Overall Survival, Progression-Free Survival, Objective Response Rate, Duration of Response, and Disease Control Rate
Perform Kaplan-Meier analysis, Cox proportional hazards models, and other time-to-event analyses
Collaborate with biostatisticians, data management, clinical teams, and cross-functional stakeholders
Provide technical leadership, programming oversight, and mentorship to statistical programmers
Review programming specifications, analysis datasets, and statistical outputs for accuracy and consistency
Support regulatory submissions and respond to health authority requests
Improve programming standards, processes, and efficiencies

Requirements

What you’ll need

Bachelor's or Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related discipline
Extensive experience in clinical statistical programming within the pharmaceutical or biotechnology industry
Strong hands-on experience with SAS programming, including SAS Base, SAS Macro, and SAS/STAT
Significant experience supporting solid tumor oncology clinical trials, preferably across Phase I, II, and III studies
Strong knowledge of oncology efficacy endpoints, including OS, PFS, ORR, and DoR
Expertise in CDISC SDTM and ADaM standards
Experience developing and validating complex TFLs for clinical study reports and regulatory submissions
Knowledge of ICH-GCP and regulatory requirements (FDA/EMA)
Excellent communication, problem-solving, and cross-functional collaboration skills
Experience with immuno-oncology and targeted cancer therapies
Exposure to clinical trials involving head and neck, lung, colorectal, breast, or other solid tumor indications
Experience with FDA or EMA regulatory submissions
Prior experience providing technical leadership and mentoring statistical programming teams

Benefits

Comp & perks

Professional development
Supportive culture
Continuous training
Close management and training
Career opportunities through working for a global CRO
Client-facing role with a high-trust environment