Principal SAS Programmer

The role of a Programmer in Phastar's Functional Service Provision team is a critical one. We are looking for an experienced, ambitious and driven individual with strong CDISC knowledge to join our FSP team.

This is a fantastic opportunity to work for a growing CRO that is recognized for its continuous learning and development opportunities, whilst also gaining direct experience of working within a pharmaceutical environment.

• 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

• Proficiency in SAS (Macros, Base, Graphs) and other statistical Programming tools.
• Experience with CDISC Standards (SDTM, ADaM) and regulatory submissions.
• Knowledge of Statistical methodologies used in clinical trials.
• 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
• Implements new ways of working utilizing a wide variety of software (e.g. SAS, R, Python).
• Strong production hands-on TFL programming skills for in-house projects.
• Have to have worked on Disclosure tables especially the Basic Results tables.
• Quick learner as if they don't have experience with Disclosure then at least they should be willing to learn.

• Serve as Lead Statistical Programmer overseeing programming deliverable across different Phases.
• Demonstrated ability to work and influence across functions, regions and cultures.
• Excellent communicator, able to convey both complex ideas and data, verbally and in writing.
• Recommends strategic decisions that impact the statistical programming function.
• Accountable for statistical programming decision making within study level.
• Plan, Prioritize, and allocate resources to meet project deadlines and regulatory submission timelines.
• Lead the development, validation, and implementation of standardized programming macros, templates, and best practices to improve efficiency.
• Collaborate with biostatisticians, data managers, and clinical teams to define data analysis requirements and ensure alignment with study objectives.
• Take ownership of statistical programming workflows, proactively identifying risks and mitigation strategies.

• Excellent oral and written communications skills.
• Comfortable challenging the status quo and proposing forward thinking innovative solutions.
• Proposes and embeds ideas around innovative solutions and leverages new ways to accelerate existing milestones.
• Inspire teamwork.
• Assess benefit risk of options.
• Focuses on priorities.
• Strong interpersonal skills.
• Strong project management and time management skills.
• Strong collaborative skills and ability to work with a cross-functional team.