Senior Statistical Programmer

This is a fully remote position, open to applicants in Taiwan.

📋 Description

• The requested services involve Statistical Programming for clinical trials from Phase I to IV using SAS (Base and Macros) and R.

• Deliverables: The services provided will comply with relevant client SOPs, WIs, policies, local regulatory requirements, ICH-GCP, and other applicable guidelines.

• Development of ADaM datasets in alignment with current ADaM standards.

• Generation of Tables, Listings, and Figures according to client specifications.

• Preparation of Subject Narratives using client templates to assist with Narrative development.

• Production of additional ancillary data streams, including but not limited to clinical registry reporting files (e.g., Clintrials.gov, EudraCT) and Bioresearch monitoring reports (BIMO).

• Quality Control (QC) of all programmed outputs.

• Creation and/or upkeep of comprehensive specification documentation.

• Development and validation of electronic submission packages that adhere to submission requirements from the FDA, EMEA, and other regulatory bodies as necessary.

• This role includes support for standalone studies as well as data integration across various studies.

• The service holder is accountable for designing, developing, and maintaining generic SAS code applicable to multiple trial types, capable of operating on various study designs while addressing study-specific scenarios informed by reliable study metadata.

• The service holder defines and maintains standard clinical data analysis metadata for clinical trials, ensuring traceability from Analysis Datasets and Analysis Results (ADaM) to Study Data Tabulation Datasets (SDTM).

• The service holder pre-configures standards in accordance with the data lifecycle plan while ensuring the traceability and lineage of the data.

• The service holder documents and effectively manages the lineage between master standards and numerous pre-configured standards.

⛳️ Requirements

• A Bachelor’s degree or higher in computer science, mathematics, or another scientific field (or equivalent theoretical/technical depth).

• An advanced degree (Master's, PhD, or equivalent) is preferred for Level 4 positions.

• Proven written and verbal communication skills.

• Proficiency in SAS is essential, while knowledge of R and Python is advantageous.

• A minimum of 4+ years of relevant experience.

• Extensive experience in utilizing SAS (Base and Macro) for the analysis of clinical trial data.

• Familiarity with clinical trial data (Study population, safety, efficacy, PK/PD) within the therapeutic area being serviced.

• A demonstrated understanding of current industry standards for the submission of clinical trial data.

• Basic knowledge of industry standards, particularly Study Data Tabulation Model (SDTM), Controlled Terminologies (CT), and associated Analysis Data Models (ADaM).

• Relevant operational experience in analysis standards (ADaM metadata and SAS Code) is preferred.

• Experience with Therapeutic Area User Guides (TAUG) is a plus.

• Foundational R programming capabilities to enable data handling and simple analyses.

• Understanding of R syntax and basic data structures, including the ability to import and export datasets and create basic data visualizations.

🏝️ Benefits

• Flexibility to work remotely.