Senior/Principal Programmer Analyst, FSP at Thermo Fisher Scientific

Key Accountabilities/Responsibilities:

The Statistical Programmer is responsible for all statistical programming activities. These responsibilities include:

• Provides relevant input in the development of the statistical analysis plan and mock tables, listings and figures.
• Performs critical review of derived datasets specifications and derived datasets (ADaM).
• Develops programs to perform QC of statistical outputs.
• Defines program specific standards for ADaM datasets. Checks compliance of CRO delivered ADaM datasets to CDISC standards.
• Verifies define.xml (for ADaM’s) and ADRG.
• Develops, validates and documents programs for additional post-hoc analyses.
• Develops, reviews, documents and performs validation of generic SAS macros, and creates a macro library.
• Supports data submission activities according to regulatory guidelines (e.g. ISS, ISE).
• Supports outsourcing programming activities and coordinates the QC of these activities.
• Can assess well time needed for all programming related activities.
• Is able to independently handle programming activities for 1 or 2 studies and integrated summaries within 1 project simultaneously.
• Take ownership to deliver a project in time.
• Is able to negotiate timelines and can assess when extra resources are needed and is able to communicate this in time.

Desired Skills and Experience:

• Excellent knowledge of SAS is a must. Knowledge in R is a plus.
• Detailed knowledge of and experience with CDISC standards is desired.
• Demonstrates ability to plan and complete the statistical programming tasks for multiple clinical trials and integrated analyses (e.g., ISS, ISE).
• Displays good communication skills and proficiency to work independently and as part of a team.
• Knowledge of ICH-GCP and other applicable legislation, with good understanding of clinical data and pharmaceutical development.
• Bachelors or higher degree in Science, Statistics, Information Technology or equivalent combination of education and related work experience.
• Minimum of 8-10 years of professional experience desired.
• Experience in handling CROs and vendors is a plus.
• Biotech experience is a plus.