We are seeking a Senior Programmer to work across multiple clinical and non-clinical studies; 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; producing, reviewing and updating complex dataset specifications (including efficacy); creating and debugging complex macros; 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.
Responsibilities:
- Program and validate datasets and SDTMs, including complex efficacy, labs, etc.
- Become independent technical expert
- Program complex non efficacy outputs/ figures
- Perform Senior Review and Deliver QC of non- statistical output
- Become involved in developing the standard macro library and take responsibility to implement standard macros within a study
- 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.
- Implement and coordinate development and maintenance of MAC standard specifications
- Be an SDTM and ADAM expert providing consultancy, advice and training
- Be aware of up and coming changes to CRT and define.xml standards and regulatory guidelines and requirements
- Implement and coordinate the development and maintenance of MAC CRT tools
- Become familiar with and follow study documentation
- Initiating projects and ideas for furthering programming development
- Ensure the principles in the MAC checklist are followed rigorously
- Develop archiving systems and processes
- 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
- Responsible for study level resources
- Provide mentoring and training to junior team members
- Attend and input to company resourcing meeting
- Point of contact for programming issues for the team, proactively ensuring everything is working cohesively
- Persuade stakeholders to follow best practice within a trial
- Develop and deliver company-wide training as and when required
- Identify areas where new processes are required
- Create, review and update processes and SOPs
- Take responsibility for study compliance with SOPs and processes
Qualifications:
- Educated to BSc or above within Computer Science, Mathematics or a Science related discipline
- Minimum of three years, leading clinical trials from the perspective of the lead programmer.
- Good awareness of clinical trial issues, design, and implementation
- Experience of regulatory submissions and associated industry guidance
- Familiarity with GCP and regulatory requirements
- Knowledge of SDTM and ADaM CDISC standards
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.
BENEFITS:
- 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
MAC Clinical Research invites applications from highly motivated candidates, with a desire to fulfil their full potential. You will be working with an organisation that sees you as an investment and is keen for you to achieve your career aspirations.
This role can be home based and therefore we require you to have a set up at home that allows you to work comfortably. This includes an appropriate desk and chair (excl. IT equipment which we will provide), please confirm you are able to do this before proceeding with your application.
Please email maccareers@macplc.com should you require any special arrangements or reasonable adjustments to be made throughout this selection process. This will enable us to accommodate your request as necessary.
