Senior Statistical Programmer

Overview

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.

WHY PHASTAR

Accredited as an outstanding company to work for, Phastar is committed to employee engagement, workplace satisfaction and ensuring a healthy work-life balance.

We offer flexible working, involvement in developing company-wide initiatives, structured training and development plans, and a truly supportive, fun and friendly environment.

What’s more, when you join our team, Phastar will plant a tree in your honour, as one of our Environmental, Social and Governance (ESG) initiatives.

So, not only would you get your dream job, you’ll also be helping to save the planet!

THE ROLE

We are seeking a Senior Programmer to work 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.

ISS and ISE experience is essential. Excellent teamwork ethos, 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 :

• 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
• Working on ISS and ISE
• 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 the same project, ensuring quality and timely delivery
• Liaise with Study Statistician and Project Manager regarding resourcing and deliverables

Qualifications

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

APPLY NOW

With the world’s 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.

We’re 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 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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