Company:
MAC Clinical Research
Location: London
Closing Date: 08/11/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
supporting regulatory submission activities; producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines. Excellent knowledge of CDISC SDTM and ADaM implementation guidelines working independently in this area; reviewing Statistical Analysis Plans (SAPs), including study specific ISS/ISE and DSMB SAPs and output shells with a view to commenting from a programming perspective. Excellent team work ethos, proactive at managing workload, willingness to help others and learn new skills from working in a team environment.
This position is remote (although can be office based or hybrid, depending on your location) and will involve occasional travel to events throughout the year.
Perform Senior Review and Deliver QC of non- statistical output
Validate and perform User Acceptance Testing (UAT) on standard macros
Identify macros requirements, communicate and perform training
Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc.
Be an SDTM and ADAM expert providing consultancy, advice and training
xml standards and regulatory guidelines and requirements
Initiating projects and ideas for furthering programming development
Act as a Lead programmer on multiple studies and project, ensuring quality and timely delivery
Liaise with Study Statistician and Project Manager regarding resourcing and deliverables
Provide mentoring and training to junior team members
Point of contact for programming issues for the team, proactively ensuring everything is working cohesively
Develop and deliver company-wide training as and when required
Educated to BSc or above within Computer Science, Mathematics or a Science related discipline
Good awareness of clinical trial issues, design, and implementation
Experience of regulatory submissions and associated industry guidance
Familiarity with GCP and regulatory requirements
MAC is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health.
Competitive salary in keeping with pharmaceutical industry standards that will reflect experience
~ Health Insurance
~ Free onsite parking
~25 days annual leave (increasing in increments to 30 days after 6 years' service)
~ Your birthday off work
This role can be home based and therefore we require you to have a set up at home that allows you to work comfortably. IT equipment which we will provide), please confirm you are able to do this before proceeding with your application.
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