Unlock the Power of Statistical Analysis
About the Role
We are seeking a highly skilled Senior Statistical Programmer to join our clinical development team. In this role, you will play a pivotal part in the analysis and reporting of clinical trial data, contributing to the success of our research programs.
This is an excellent opportunity for someone with a strong background in SAS programming and clinical trial analytics to make a meaningful impact in a dynamic and innovative environment.
Key Responsibilities
* Develop, implement, and maintain programs for the analysis and reporting of clinical trial data.
* Review trial documentation and provide feedback from a statistical programming perspective.
* Define and design project and trial analysis datasets and metadata, including complex derivations and data pooling.
* Collaborate with statisticians and trial programmers to ensure accurate data mapping and analysis.
* Generate Tables, Listings, and Figures (TLFs) in accordance with trial documentation and statistical guidelines.
* Perform and document quality control (QC) checks in line with SOPs and best practices.
* Deliver high-quality outputs to statisticians and clinical teams within project timelines.
* Maintain comprehensive documentation for all programming deliverables and ensure proper filing in the eTMF.
* Provide technical guidance and support to colleagues, and contribute to departmental standards and process improvements.
* Support the implementation of tools and systems that enhance data analysis and workflow efficiency.
* Ensure compliance with ICH-GCP regulations and internal SOPs.
Requirements
* University degree (or equivalent) in mathematics, informatics, or a related scientific field.
* Minimum of 4 years of experience in statistical programming, with at least 3 years in a pharmaceutical or CRO setting.
* Advanced proficiency in SAS programming and statistical analysis for clinical trials.
* Solid understanding of CDISC standards, particularly SDTM and ADaM.
* Basic knowledge of R; familiarity with other programming languages and data management tools is a plus.
* Strong analytical and problem-solving skills with a structured and logical approach.
* Proven ability to work independently and meet deadlines while adhering to SOPs and specifications.
* Excellent communication skills in English, both written and verbal.
* Knowledge of international clinical research regulations (ICH-GCP).
What We Offer
We offer a collaborative and dynamic work environment that fosters growth and development. As a Senior Statistical Programmer, you will have the opportunity to work on challenging projects, develop your skills, and contribute to the success of our research programs.
In addition to a competitive salary and benefits package, we offer opportunities for professional growth and development, including training, mentorship, and career advancement.