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, part-time hours, 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
Demand for our Functional Service Provision is growing – we are therefore looking for a driven and passionate Statistical Programmer to join our reputable FSP team to support one of our fantastic US based pharmaceutical clients. We are looking for an experienced Programmer with Data anonymization & disclosure expertise, who is versatile and flexible to work on various therapeutic areas. The successful individual must have strong production hands-on TFL programming skills for in-house projects, should have worked on Disclosure tables especially the Basic Results tables.
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.
This position is remote, and the successful candidate can be located anywhere in India
Responsibilities
- Program and validate SDTMs and ADaMs, including complex efficacy, labs, etc.
- Proficiency in SAS (Macros, Base, Graphs) and other statistical Programming tools.
- Have to have worked on Disclosure tables especially the Basic Results tables.
- Program complex non efficacy outputs/figures
- Develop and debug complex macros
- Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies
- Review simple 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
- Become familiar with and follow study documentation
- 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
Qualifications
- BSc, MSc or PhD in Mathematics, Science or IT related discipline
- 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.
