Overview
Work as a experienced programmer across multiple clinical studies; supporting regulatory submission activities; producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines. Good knowledge of CDISC SDTM and ADaM implementation guidelines working with minimal guidance in this area; producing, reviewing and updating non-efficacy/non-complex data specifications; creating and debugging 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. Line managing members of staff, contributing to management meetings.
Responsibilities
Employees may be required to perform some or all of the following:· 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· 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 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· 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 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 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 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
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
About Phastar
Phastar is an award-winning biometrics and data science CRO, trusted by pharma, biotech, and medical device companies worldwide. With a global team of data specialists, we bring expertise, precision, and pace to every trial, because behind every data point is a patient waiting for treatment.
We transform complex data into clear, actionable intelligence, helping accelerate drug development, and bring life-changing therapies to patients faster.
Awards & Recognition
SCRIP – Best Contract Research Organization, Specialist Provider
Citeline – 2025 Award Winner
Fierce CRO Awards – Recognized Industry Leader
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Be part of a team known for technical expertise, quality, and impact. We value Excellence, Collaboration, Integrity, Innovation, and Passion—and we seek team members who embody these qualities. Apply today!
Phastar is committed to the principles and practices of equal opportunities and to encourage 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, color, 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.
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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.
