Overview

Principal/Senior Statistical Programmer (Contract) – remote 12 month contract with a global pharmaceutical brand. The role focuses on delivering programming and statistical support for clinical drug development, and maintaining end-to-end standards, analysis and reporting tools, and the information infrastructure.

Responsibilities

• Collaborate with the Programming Leader to lead and/or support aspects of the programming effort to deliver technical programming and information components of a project.
• Data submission strategy (e.g., managing legacy data, pooling data).
• Oncology experience is essential, preferably study lead experience.
• Respond to regulatory agency queries.
• Develop Tables, Figures and Listings (TFLs).
• Prepare and contribute to Development Safety Update Reports (DSURs).
• Prepare Periodic Benefit-Risk Evaluation Reports (PBRERs).
• Prepare or manage Office of Scientific Investigations (OSI) data sets and listings.
• Regulatory and/or payer submission related analysis data sets and/or TFLs.
• Create associated quality and process documentation per applicable business processes.
• Work with Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) data sets.
• Pharmacokinetics/pharmacodynamics data preparation and analysis.
• Manipulate and analyze adjudicated data.
• Data preparation and analysis for Global Medical Affairs work.
• Timely upload of documents to eTMF.

Qualifications

• BSc in mathematics, statistics, engineering, computer science, or life or social sciences.
• Advanced SAS programming knowledge and experience.
• Knowledge of database set-up and report publishing requirements.
• Advanced knowledge of technical and regulatory requirements related to the role.
• Knowledge of CDISC standards (e.g., CDASH, SDTM, ADaM) and industry best practices.
• Advanced knowledge and experience of clinical drug development or healthcare.

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Research, Analyst, and Information Technology

Industries

• Pharmaceutical Manufacturing and Research Services