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.
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