Phastar

Human Resources

• Provides high-quality HR advice and guidance to managers and employees
• Supports the delivery of a fair, consistent, and legally compliant people service
• Leads on employee relations issues and coaches managers in effective people management
• Contributes to wider HR initiatives that support organizational success, culture, and employee wellbeing
• Operates HR support

HR Business Partner

Software Engineer

• As a Senior Statistical Programmer, you will be working embedded within the sponsor FSP team.
• This role will be using both SAS & R Programming within the clinical domain.
• 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
• Lead Team and be responsible for creation of CRT packages
• Perform R Programming on Datasets
• Program complex non efficacy outputs and figures
• Perform senior review and deliver QC of non-statistical output
• Create, QC and update complex dataset specifications

Principal Statistical Programmer

• 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
• 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)
• Ensuring the principles in the PHASTAR checklist are followed rigorously
• Act as a Lead programmer on multiple studies and project, ensuring quality and timely delivery

Principal Programmer, Oncology

• Lead and deliver SDTM mapping and conversion activities for RWD to CDISC standards
• Interpret complex RWD datasets and map them to appropriate SDTM domains, variables, and controlled terminology
• Develop and review ECRT packages including aCRF, Define.xml, and CSDRG
• Act as a Subject Matter Expert (SME) in SDTM and CDISC standards
• Work independently on complex programming tasks with minimal supervision
• Collaborate cross-functionally and communicate effectively with stakeholders
• Document key decisions, mappings, and discussions (PowerPoint, meeting notes, etc.)
• Ensure the principles in the Phastar checklist are followed rigorously
• Archive study documentation following instructions in supplied SOPs
• Act as a Lead Programmer, ensuring quality and timely delivery
• Liaise with the Study Statistician and Project Manager regarding resourcing and deliverables
• Assess and monitor study level resources
• Point of contact for programming issues for the team, proactively ensuring everything is working cohesively
• Persuade stakeholders to follow best practice within a trial
• Assist in development of internal training courses

Principal Programmer – RWD, SDTM

• 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

Senior Statistical Programmer

• 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

HR Business Partner

Principal Statistical Programmer

Principal Programmer, Oncology

Principal Programmer – RWD, SDTM

Senior Statistical Programmer

Senior/Principal Programmer – Data Anonymization