Hobson Prior are looking for a Senior Statistical Programmer to join a clinical-stage biotech organisation who are focused on innovative treatment for severe autoimmune diseases and cancer. You will focus on programming statistical analysis datasets, outputs and performing the QC thereof and additionally will ensure CDSIC compliance of ADaM datasets.

Job Responsibilities:

• Accountable to provide relevant input in the development of the CRF, statistical analysis plan and mock tables, listings and figures.
• Performs critical review of derived datasets specifications and derived datasets (ADaM).
• Verifies define.xml (for ADaM's).
• 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.
• Supports outsourcing programming activities and oversees the QC of these activities.
• Verifies define.xml (for ADaM's).
• 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.
• Partakes in project team meetings.
• Supports data submission activities according to regulatory guidelines (e.g. ISS, ISE).

Key Skills:

• Displays good communication skills.
• Proficiency to work independently and as part of a team.

Requirements:

• Bachelors or higher degree in Science, Statistics, Information Technology or equivalent combination of education and related work experience.
• Excellent knowledge of SAS is a must. Knowledge in R is a plus.
• A minimum of 3-4 years of professional experience desired.
• Experience in managing CROs and vendors is a plus.
• Demonstrates ability to plan and execute the statistical programming tasks for multiple clinical trials and integrated analyses (e.g., ISS, ISE).
• Knowledge of ICH-GCP and other applicable legislation, with good understanding of clinical data and pharmaceutical development.
• Biotech experience is a plus.
• Thorough knowledge of and experience with CDISC standards is desired.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.