Overview
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, therefore we are looking for an experienced, ambitious and driven Programmer to join our Center of Excellence and submissions team. The expectation is that the candidate has very strong CDISC knowledge.
As Senior/Principal Programmer, you will be fully integrated into our sponsor’s submission excellence team as a key contributor, providing hands-on technical eSUB expertise including guidance, define, reviewer’s guide, for submission of clinical trial data for FDA, PMDA and EMA regulatory agencies.
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.
Responsibilities
Employees may be required to perform some or all of the following:
Program complex non efficacy outputs/ figuresPerform Senior Review and Deliver QC of non- statistical outputDevelop and debug complex macrosBecome involved in developing the standard macro library and take responsibility to implement standard macros within a studyCreate, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etcReview more complex study design SAP without supervisionReview all shells without supervision and provide feedbackKnowledge, interpretation and implementation of current SDTM, ADAM standardsKnowledge of FDA CRT requirements including define.xml and define.pdfLead team and be responsible for creation of CRT packagesBecome familiar with and follow study documentationLead a team for furthering programming developmentEnsure the principles in the PHASTAR checklist are followed rigorouslyArchive study documentation following instructions in supplied SOPsAct as a Lead programmer on multiple studies under same project, ensuring quality and timely deliveryLiaise with Study Statistician and Project Manager regarding resourcing and deliverablesResponsible for study level resourcesAttend and input to company resourcing meetingPoint of contact for programming issues for the team, proactively ensuring everything is working cohesivelyPersuade stakeholders to follow best practice within a trialDevelop and deliver company-wide training as and when requiredCreate, review and update processes and SOPsTake responsibility for study compliance with SOPs and processes
Qualifications
Educated to BSc or above within Computer Science, Mathematics or a Science related disciplineExperience of programming to SDTM and ADaM standardsMust be a strong senior or entry level principal. Experience with ISS/ISE. Submission experience. Experience with leading studies.Strong hands-on programming background. Good communication skills.
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!
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.
