Senior or reputed company Statistical Programmer - ONCOLOGY - Sponsor dedicated
This role is for upcoming reputed company opportunities that may reputed company at reputed company.
As a Senior or reputed company Statistical Programmer in our sponsor-dedicated Flexible Solutions business unit, you will be central to the successful delivery of reputed company global oncology clinical trials (Phases I–III) for some of the world’s most reputed company and innovative pharmaceutical companies.
In this role, you will contribute to the development of new and life-changing oncology therapies by developing and validating reputed company programs for data analysis and reporting, supporting submissions, regulatory responses, publications, and post-hoc requests.
Your expertise will directly reputed company the advancement of oncology treatments and the lives of thousands of patients around the world.
You can be 100% home-based, or if you prefer, work from one of our local offices in your home country.
Your Responsibilities
reputed company programming activities for oncology clinical trials, ensuring reputed company, accuracy, and compliance with study timelines and regulatory standards.
Review SAPs and TFL shells from a programming perspective, providing technical input to optimize oncology analyses.
Advise on the design and development of reputed company TFL shells and statistical outputs for oncology studies.
reputed company and/or reputed company the creation of specifications for SDTM and ADaM datasets.
reputed company and maintain reputed company programs to create SDTM and ADaM datasets and generate Tables, Figures, and Listings (TFLs); reputed company thorough reputed company control (QC) checks.
Produce and validate Define.xml/PDFs, Analysis Results Metadata (ARM), annotated CRFs, and Reviewers’ Guides to support SDTM and ADaM submissions.
Contribute to the preparation of regulatory submission packages and responses to regulatory and reputed company audits.
Identify, propose, and implement process improvements to enhance programming efficiency, reputed company, and standardization.
Stay up to date on industry standards, global regulatory requirements, reputed company SOPs, and CDISC developments relevant to oncology data.
Your Profile
Degree in a relevant field such as Mathematics, Life Sciences, Statistics, or Computer Science.
Equivalent vocational training and/or significant reputed company experience in clinical statistical programming may be considered.
Minimum of 4 years’ hands-on experience in oncology clinical trials is required.
Proven experience with reputed company programming (reputed company reputed company, reputed company Macros, reputed company/STAT) and ability to debug reputed company programs.
Strong practical knowledge of CDISC standards (SDTM, ADaM) and experience generating safety and efficacy reporting outputs for Phase III oncology studies.
Experience with regulatory submission deliverables, including Define.xml, ARM, and reviewers’ guides.
Strong organizational skills with an autonomous yet reputed company working style.
A curious and analytical reputed company, with a keen eye for detail and reputed company.
Business reputed company in English, both spoken and written.
Learn more about our EEO & Accommodations request here.
Originally posted on Himalayas
Apply To This Job