Job Description

Overview:
Work as a principal programmer 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. Participate in the review of Case Report Forms (CRFs), CRF annotations, Statistical Analysis Plans, SDTM/ADAM specifications, and datasets, and TLFs.
Limited management of FSP colleagues. Apply technical knowledge and experience to deliver statistical programming deliverables to support study teams with limited supervision
Ensures excellence and high quality in the programming of analysis ready datasets, tables, listings, and figures for which they are responsible 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.
Responsibilities:
Employees may be required to perform some or all of the following:
xc2xb7 Program and validate datasets and SDTMs, including complex efficacy, labs, etc.
xc2xb7 Become independent technical expert
xc2xb7 Program complex non efficacy outputs/ figures
xc2xb7 Perform Senior Review and Deliver QC of non- statistical output
xc2xb7 Become involved in developing the standard macro library and take responsibility to implement standard macros within a study
xc2xb7 Validate and perform User Acceptance Testing (UAT) on standard macros
xc2xb7 Identify macros requirements, communicate and perform training
xc2xb7 Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc
xc2xb7 Implement and coordinate development and maintenance of PHASTAR standard specifications
xc2xb7 Be an SDTM and ADAM expert providing consultancy, advice and training
xc2xb7 Be an CRT expert providing consultancy, advice and training
xc2xb7 Be aware of up and coming changes to CRT and define.xml standards and regulatory guidelines and requirements
xc2xb7 Implement and coordinate the development and maintenance of PHASTAR CRT tools
xc2xb7 Become familiar with and follow study documentation
xc2xb7 Initiating projects and ideas for furthering programming development
xc2xb7 Ensure the principles in the PHASTAR checklist are followed rigorously
xc2xb7 Develop archiving systems and processes
xc2xb7 Act as a Lead programmer on multiple studies and project, ensuring quality and timely delivery
xc2xb7 Liaise with Study Statistician and Project Manager regarding resourcing and deliverables
xc2xb7 Responsible for study level resources
xc2xb7 Attend and input to company resourcing meeting
xc2xb7 Point of contact for programming issues for the team, proactively ensuring everything is working cohesively
xc2xb7 Persuade stakeholders to follow best practice within a trial
xc2xb7 Develop and deliver company-wide training as and when required
xc2xb7 Identify areas where new processes are required
xc2xb7 Create, review and update processes and SOPs
xc2xb7 Take responsibility for study compliance with SOPs and processes Qualifications:
xc2xb7 Educated to BSc or above within Computer Science, Mathematics or a Science related discipline
xc2xb7 SAS Programming Experience within the pharmaceutical industry
xc2xb7 Good awareness of clinical trial issues, design, and implementation.
xc2xb7 Experience of regulatory submissions and associated industry guidance
xc2xb7 Familiarity with GCP and regulatory requirements
xc2xb7 Knowledge of SDTM and ADaM CDISC standards
APPLY NOW
With the worlds eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality, and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. Were committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun, and friendly working environment.
Should you feel that you have the right skill set and motivations for this position, please apply! Please note that we are considering candidates located anywhere in the UK & selected European countries as this role can be carried out remotely.
Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all.
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