Manager, Statistical programming Consultant- Oncology - Remote

United States

full time

Remote

senior

H1B: yes

ClinChoice Manager, Statistical Programming Consultant at ClinChoice leads statistical programming activities for oncology clinical trials. The role includes managing teams, ensuring compliance with standards, and delivering clinical trial datasets and reports.

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.

Qualification

Prior experience in a managerialStrong knowledge of CDISC standardsExperience with oncology endpointsThe Application ProcessOnce you have submitted your CVWho will you be working for?About ClinChoice

Required

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

Company

ClinChoice

View company page

Source: greenhouse

Active within the past hour

Remote-friendly

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