Descrição da Função
The company you're going to work at:
Multinational company specializing in information technology services.
Your new role:
We are seeking a skilled Study Statistician to support the design, analysis, and reporting of clinical trials and scientific research studies. The role involves collaboration across cross-functional teams, contributing to protocol development, statistical analysis plans, and programming specifications. The candidate will assist in the implementation of sound statistical methodologies and ensure high-quality deliverables aligned with regulatory standards.
The Senior Statistician collaborates with team members (both internal and external) to provide high-quality, reliable statistical expertise and support;
Additionally. they perform and oversee quality control (QC) of data displays with inferential statistics. Also, Senior Statistician conduct QC analysis datasets prepared by others, maintain project administration files (including protocols, annotated CRFs, statistical analysis plans, annotated shells, programming/QC rules, tracking logs, and project communications).
What you need to be successful:
Key Responsibilities
Support protocol and SAP development, including TFL shell creation;
Write and review SDTM and ADaM specifications for moderately complex studies;
Perform production and validation programming of SDTM, ADaM, and TLFs;
Identify data collection instruments and report data issues or assumption violations;
Provide specifications for derived variables and analysis datasets;
Collaborate on database lock preparation and publication of scientific research;
Conduct statistical analyses under supervision and interpret results accurately;
Ensure consistency and accuracy in reports, tables, listings, and figures;
Communicate statistical concepts clearly to non-statisticians;
Participate in sponsor meetings across US time zones.
Qualifications
Master’s degree in Statistics, Biostatistics, or related field (PhD preferred);
Minimum 4 years of industry experience with a Master’s (or 1+ year with PhD);
Proven ability to lead projects and collaborate in diverse team environments;
Strong foundation in statistical theory and advanced methodologies;
Proficient in SAS programming and familiar with regulatory guidelines;
Experience with clinical trial data analysis and submission preparation;
Advanced knowledge of SAS procedures;
Languages Required: English C1.
Some travel (5%) may be required with a potential of travel occurring over weekends.
Work Location : Remote
Office hours (Eastern Daylight Time)
14:30 PM - 22:30 PM (Lisbon Time)
09:30 AM- 17.30 PM (Client Time)
Next step:
In case you are interested in this opportunity, click on "Apply Now" to send us your updated CV.
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