Senior Statistical Programmer - FSP - ADaM Specialist

at  Phastar

THE COMPANY

Phastar is a multiple award-winning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services. With offices across the UK, US, Germany, Denmark, Kenya, Australia, India, China and Japan, Phastar is the second largest specialized biometrics provider globally, and the largest in the UK.
Our unique approach to data analysis, “The Phastar Discipline”, has led us to build a reputation for outstanding quality. With this as our core focus, we’re looking for talented individuals who share our passion for quality and technical expertise to join our team.

Qualifications:

• Educated to BSc or above within Computer Science, Mathematics or a Science related discipline
• SAS Programming Experience within the pharmaceutical industry
• 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 standard

We are seeking a Senior Programmer I to work embedded within our sponsor site to work on Oncology Projects. This role will see you involve in oversight of vendor programming, working on client systems and adhering to sponsor SOP’s.
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.
• Adhere to client SOPs and work on client systems
• Oversight of Vendor Programming
• Knowledge of FDA CRT requirements including define.xml and define.pdf
• Lead team and be responsible for creation of CRT packages
• 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 PHASTAR standard specifications
• Be an SDTM and ADAM expert providing consultancy, advice and training
• Be an CRT 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 PHASTAR CRT tools
• Become familiar with and follow study documentation
• Initiating projects and ideas for furthering programming development
• Ensure the principles in the PHASTAR 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
• Attend and input to company resourcing meeting
• Point of contact for programming issues for the team, proactively ensuring everything is working cohesively

Qualifications:

• Educated to BSc or above within Computer Science, Mathematics or a Science related discipline
• SAS Programming Experience within the pharmaceutical industry
• 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