Overview
About Phastar
Phastar brings data to life! We are an award-winning specialist biometrics contract research organization (CRO) that works with pharmaceutical, biotechnology and medical device companies to provide statistical consulting, analysis and reporting, data management, and data science services.
Our unique approach to data analysis, “The PHASTAR Discipline”, has gained us a reputation for outstanding quality. With this as our core focus, we’re looking for a talented individual who shares our passion for quality and technical expertise to join our team…could this be you?!
Why Phastar
Phastar is a company that cares. We strive to be the premier biometrics provider to work with, and to work for, and we take our responsibility to do our part for the environment and our community seriously.
Our pro bono scheme provides charities access to our biometrics experts at no cost; we source sustainable products to reduce our carbon footprint and, when you join our team, we will plant a tree in your honour as part of our rewilding project. Learn more about our ESG initiatives here.
Caring for YOU
YOUR career, YOUR work/life balance, YOUR PHASTAR experience.
- Total flexibility – working hours that work for YOU.
- Remote, office or hybrid – a working arrangement that works for YOU.
- Culture of learning – continuously develop YOUR knowledge and share YOUR expertise with others.
- Career Path - tailored to YOUR strengths and aspirations.
- Monthly well-being checks – to ensure you get the support you need.
- Fun, friendly working environment – experience PHASTAR’s famous social events throughout the year.
Work as a senior programmer on clinical and non-clinical trials; producing complex datasets and outputs to excellent quality whilst adhering to deliverable timelines. Good knowledge of 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. Excellent team work ethos, willingness to help others and learn new skills from working in a team environment.
Responsibilities
Sound a good fit for you? Here are some of the key contributions you would be making as a fully integrated member . · 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 a single study, 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
Qualifications
The skills and experience you’ll bring to the role…
· BAchelors 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.· Familiarity with GCP and regulatory requirements· Experience of programming to SDTM and ADaM standards
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.
Important notice to Employment businesses/ Agencies
Phastar does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Phastar. Phastar shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
