Randomization is the process of assigning trial subjects to study material relating to treatment or control group using an element of chance to determine the assignments and is the most important design technique for avoiding bias in interventional clinical trials, next to blinding.

The scope of the Randomization Office comprises the full accountability for one of the most at-risk processes in clinical development: the translation of complex and accelerated study designs into appropriate IRT application set-up, ensuring execution of set-up and maintenance of study blinding and integrity. Stakeholders are not only in Biostatistics, but also with Clinical teams, ClinOps, Supplies teams, Safety and Tech.

The Randomization Office Analyst supports the Randomization Office Leader in the operational implementation of randomization and unblinding processes in all GSK trials.

The Randomization Office Analyst role requires collaboration skills, knowledge of clinical trials dynamics and processes, in combination with technical skills. It requires to be able to pick up selected requests coming from multiple stakeholders in and out of Biostatistics and being able to maintain good cross-functional relationships in collaboration with the Randomization Office Leader.

Key responsibilities:

As Randomization office Analyst you will:

• Support the appropriate set-up and monitoring of randomization and blinding of clinical trials in GSK IRT systems across all products.
• Execute requests from the study teams for randomized subsets of subjects across all products (immunogenicity subset for Vaccines trials).
• Ensures that study documentation for randomization and unblinding is consistent and comply with company standards.
• Ensure completeness of study eTMF documentation pertaining to the randomization and unblinding process, including management monitoring. The management monitoring activities might be extended to all Biostatics activities outside of randomization and unblinding.
• Supports randomization process continuous improvement initiatives.

Note that since this function is unblinded for all trials, other statistical or programming activities for active trials are not allowed, except when specifically requested, for DMC or interim analysis.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelors degree in Mathematics, Computer Science, Life Science or equivalent in experience
• Experienced in participating in improvement initiatives from inception through to completion involving both multi-disciplinary and geographically remote partners
• Ability to work in multi-cultural teams; positive team spirit and interpersonal skills
• High level of flexibility and sense of urgency
• Operates with a high degree of integrity, responsibility, independence and initiative
• Good familiarity with data and understanding of data flows
• Experience with randomization/IVRS system
• Good understanding of regulations including ICH-GCP
• Fluent English (spoken and written)

Preferred Qualifications:

• Strong quality and business excellence focus
• Strong customer focus
• Good change management skills
• Good communication and presentations skills
• Good knowledge of SAS programming
• Basic knowledge of CDISC and ADaM

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.

With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.

Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.

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