Consultant Statistician (remote-based)

Hobson Prior are seeking a skilled Consultant Statistician to join an award-winning, global, data focused CRO on a contract basis. This exciting role will allow you to work remotely in the UK.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Formulates TLG shells/specifications and programming notes based on SAP and analysis/ADaM datasets.
• Delivers advanced input into statistical sections and overall consistency of clinical study protocols.
• Develops and reviews statistical analysis plans. Determines appropriate analyses for clinical endpoints based on input from the protocol and the client.
• Performs senior-level reviews and is responsible for the datasets and outputs of a project. Ensures consistency with the SAP and reviews for correctness and quality.
• Collaborates with the programming team to deliver definitions for analysis/ADaM datasets to be used for final analyses. Develops specifications and reviews datasets based on what is needed for the planned tables, listings and graphs (TLGs).
• Generates and reviews randomization schedules per the protocol and randomization specifications.
• Works with the project management group to ensure timelines are appropriate given the scope of the project.
• Is familiar with and stays current with the latest industry practices and updated regulatory guidelines.
• Communicates competently and independently with client to coordinate the statistical and programming considerations of the project.
• Establishes strong understanding of ICH guidelines, as applicable to statistics.
• Practices good internal and external customer service.
• Partners with the data management team to review data collection and helps ensure data quality throughout the clinical trial.
• Performs and/or coordinates the preparation, execution, reporting and documentation of high-quality statistical analysis according to the SAP.
• Responsible for the statistical considerations in FDA submissions for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy, including but not limited to ISS/ISE SAP, data integration plan and oversight of all integrated analyses.
• Delivers high level of support to the programmers and medical writers on all statistical matters according to client requirements.
• Prepares and reviews statistical methods and results sections for the clinical study report (CSR) with in-house medical writers.
• Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.
• Produces sample size calculations appropriate for the primary endpoint and based on input from the protocol.

Key Skills:

• Excellent mathematical and problem solving skills.
• Proficiency with MS Office applications (e.g., Word, PowerPoint and Excel).
• Good interpersonal, oral, and written communication skills.

Requirements:

• Master of Science with four (4) plus years relevant work experience or PhD (in statistics of equivalent) with two (2) plus years of relevant years of work experience.
• Strong knowledge of and experience with SAS.
• Able to be in a hands-on role by digging into data and using SAS to validate datasets and outputs.
• Advanced knowledge of the statistical considerations involved in drug development including hands-on experience with clinical trial data.
• Strong knowledge of study designs and statistical analysis methods.
• Strong familiarity with a variety of clinical data and databases.
• Working knowledge of SDTM/ADaM standards.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.