Senior / Principal Programmer-Data anonymization

Work as a senior programmer on clinical and non-clinical trials; producing complex datasets and outputs to excellent quality whilst adhering to deliverable timelines. Good knowledge of CDISC SDTM and ADaM implementation guidelines; producing, reviewing and updating complex data specifications; creating and debugging complex macros; understanding Statistical Analysis Plans (SAPs) and output shells for day to day programming activities. Excellent team work ethos, willingness to help others and learn new skills from working in a team environment.

Employees may be required to perform some or all of the following: · Program and validate datasets and SDTMs, including complex efficacy, labs, etc. · Program complex non efficacy outputs/ figures · Perform Senior Review and Deliver QC of non- statistical output · Develop and debug complex macros · Become involved in developing the standard macro library and take responsibility to implement standard macros within a study · Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc · Review more complex study design SAP without supervision · Review all shells without supervision and provide feedback · Knowledge, interpretation and implementation of current SDTM, ADAM standards · Knowledge of FDA CRT requirements including define.xml and define.pdf · Lead team and be responsible for creation of CRT packages · Become familiar with and follow study documentation · Lead a team for furthering programming development · Ensure the principles in the PHASTAR checklist are followed rigorously · Archive study documentation following instructions in supplied SOPs · Act as a Lead programmer on multiple studies under same project, ensuring quality and timely delivery · Liaise with Study Statistician and Project Manager regarding resourcing and deliverables · Responsible for study level resources · 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 · Create, review and update processes and SOPs · Take responsibility for study compliance with SOPs and processes

Technical Skills: 

• Experience with CDISC Standards (SDTM, ADaM) and regulatory submissions. 

• Understand Clinical trial data very well.  

• Strong understanding of clinical trial data flow, from raw datasets to submission-ready formats. 

• Experience with multiple therapeutic areas – so should have worked on a few Tas  

• Strong production hands-on TFL programming skills for in-house projects.   

Preferred Skills: 

• Data anonymization 

• Disclosure data.  

· Educated to BSc or above within Computer Science, Mathematics or a Science related discipline · SAS Programming Experience within the pharmaceutical industry · SAS Programming Experience within the pharmaceutical industry · Good awareness of clinical trial issues, design, and implementation. · Familiarity with GCP and regulatory requirements · Experience of programming to SDTM and ADaM standards"

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