Principal Statistical Programmer

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Principal Statistical Programmer

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Phastar
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Principal Statistical Programmer

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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
We are seeking a Principal Programmer to work across multiple clinical and non-clinical studies; Line management skills are a must have, supporting regulatory submission activities; producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines. Excellent knowledge of CDISC SDTM and ADaM implementation guidelines working independently in this area; producing, reviewing and updating complex dataset specifications (including efficacy); creating and debugging complex macros; reviewing Statistical Analysis Plans (SAPs), including study specific ISS/ISE and DSMB SAPs and output shells with a view to commenting from a programming perspective. Excellent team work ethos, proactive at managing workload, willingness to help others and learn new skills from working in a team environment
This position is remote (although can be office-based or hybrid, depending on your location) and will involve occasional travel to events throughout the year
Responsibilities
Program and validate datasets and SDTMs, including complex efficacy, labs, etc.
Become independent technical expert
Program complex non efficacy outputs/ figures
Perform Senior Review and Deliver QC of non- statistical output
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.
Implement and coordinate development and maintenance of PHASTAR standard specifications
Be an SDTM and ADAM expert providing consultancy, advice and training
Be an 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
Initiating projects and ideas for furthering programming development
Ensure the principles in the PHASTAR checklist are followed rigorously
Develop archiving systems and processes
Act as a Lead programmer on multiple studies and project, 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
Identify areas where new processes are required
Create, review and update processes and SOPs
Qualifications
Educated to BSc 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
Experience of regulatory submissions and associated industry guidance
Familiarity with GCP and regulatory requirements
Knowledge of SDTM and ADaM CDISC standards
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! Please note that we are considering candidates located anywhere in the UK, Germany, Spain or France 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/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
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Seniority level

Seniority level Mid-Senior level
Employment type

Employment type Full-time
Job function

Job function Analyst
Industries Research Services, Pharmaceutical Manufacturing, and Biotechnology Research
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