Principal Statistical Programmer

PHASTAR

  • United Kingdom
  • Permanent
  • Part-time
  • 29 days ago
Overview:THE COMPANYPhastar 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 PHASTARAccredited 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 ROLEDemand for our Functional Service Provision is growing, therefore we are looking for an experienced Statistical Programmer to join our reputable FSP team at Principal level. As a Principal Programmer, you will hold a combined project leadership and technical hands-on programming role. Working specifically on oncology studies, the successful candidate will lead assigned studies, ensuring they are delivered to optimal quality, on time and on budget.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.The role is remote (although can be office based or hybrid, depending on your location). The successful candidate can be located in the UK or Europe. Responsibilities:Employees may be required to perform some or all of the following…
  • Create, validate and maintain CDISC SDTM and ADaM datasets in compliance with regulatory submissions
  • Act as an independent technical expert to support our FSP client and FSP team
  • Program complex non efficacy outputs/figures
  • Perform Senior Review and Deliver QC of non- statistical outputs
  • Coordinate and perform code reviews
  • Become involved in developing the standard macro library and take responsibility to implement standard macros within a study
  • Validate and perform User Acceptance Testing (UAT) on standard macros
  • Identify macros requirements, communicate and perform training
  • Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc.
  • Implement and coordinate development and maintenance of Phastar standard specifications
  • Be an SDTM and ADaM expert providing consultancy, advice and training
  • Be a CRT expert providing consultancy, advice and training
  • Be aware of up-and-coming changes to CRT and define.xml standards and regulatory guidelines and requirements
  • Implement and coordinate the development and maintenance of Phastar CRT tools
  • Become familiar with and follow study documentation
  • Provide Strategic Leadership for the growth of the group in line with company objectives
  • Ensure the principles in the Phastar checklist are followed rigorously
  • Develop archiving systems and processes
  • Ensure documentation for direct reports is audit ready at all times
  • Act as a Lead Programmer on multiple studies and project, ensuring quality and timely delivery
  • Liaise with the Study Statistician and Project Manager regarding resourcing and deliverables
  • Responsible for study level resources and resolving resourcing issues with direct reports
  • Attend and input to company resourcing meetings
  • Act as point of contact for programming issues for the team, proactively ensuring everything is working cohesively
  • Persuade and influence stakeholders to follow best practice within a trial
  • Develop and deliver internal and external training; identify non-technical training needs for direct reports
  • Identify areas where new processes are required and work with Operational Excellence team to implement new processes
  • Independently work and prioritize projects
Qualifications:
  • BSc or above within Computer Science, Mathematics or a Science related discipline
  • Extensive SAS programming experience within a CRO setting, clinical trials unit or pharmaceutical/biotechnical company
  • Experience with CDISC Standards (SDTM, ADaM) and regulatory submissions
  • Experience of regulatory submissions and associated industry guidance
  • Good awareness of clinical trial issues, design, and implementation
  • Familiarity with GCP and regulatory requirements
  • Proficiency in SAS (Macros, Base, Graphs) and other statistical programming tools
  • Strong understanding of clinical trial data flow, from raw datasets to submission-ready formats
  • Experience with Define.xml, Reviewer’s Guide (SDRG, ADRG) and regulatory compliance documentation
  • Ability to lead
  • Strong experience on oncology efficacy endpoints (preferable but not essential)
  • Excellent communication, relationship building and organisational skills
APPLY NOWWith 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 or Europe 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.Important notice to Employment businesses/AgenciesPhastar 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.

PHASTAR