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 at phastar.com/cares.
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.
- Regular well-being checks – to ensure you get the support you need.
- Fun, friendly working environment – experience PHASTAR’s famous social events throughout the year.
Responsibilities
THE ROLE
Demand for our Functional Service Provision is growing, and we’re looking for talented individuals who share our passion for quality and technical expertise to join our FSP team.
Our FSP positions provide the unique 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 sponsor’s pharmaceutical environment.
As a Senior Statistical Programmer working within FSP, you will be 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. Excellent team work ethos, willingness to help others and learn new skills from working in a team environment. Individual should be a self-starter and comfortable working alone as well as within a diverse team.
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· 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· Lead team and be responsible for creation of CRT packages· 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· Liaise with Study Statistician and Project Manager regarding resourcing and deliverables· Responsible for 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
Qualifications
· Educated to BSc or above within Computer Science, Mathematics or a Science related discipline· SAS Programming Experience within the pharmaceutical industry· 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"
Keen to be considered for the role? APPLY NOW to submit your application.
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.
