Phastar

Role Description As a Data Scientist with strong R programming and R Shiny experience, you will develop data solutions that support clinical trial delivery, data review and decision-making. You will build dashboards, visualisations and analytical tools that turn complex data into clear, actionable insights. - Develop R and R Shiny dashboards and applications for clinical trial data review and decision-making - Build reusable R code, functions and workflows to improve consistency and automation - Create data visualisations and reports that translate complex data into actionable insights - Enhance R Shiny applications through testing, documentation and user feedback - Identify opportunities to improve efficiency through automation and reusable tools Qualifications - Experience working within a clinical trials environment (CRO, pharma or academia) - Previous experience with R Programming & R shiny - Experience in CDISC is highly desirable - MSc or higher in Statistics, Mathematics or related field Benefits - Remote working and flexible working hours - Career development, mentorship, and continuous learning - Supportive, friendly, and collaborative culture - Making a Positive Impact: As a B-Corp™ organization, we are committed to sustainability, solid responsibility and strong ethical governance through our ESG initiatives Company Description 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

Role Description As a Senior Data Manager specializing in clinical trials across multiple sponsors and therapeutic areas, you will lead the study, providing expert data management guidance to the project team and providing study oversight, acting as the primary source of data management expertise and supporting the team in achieving study objectives and ensuring data integrity throughout all phases of the trial. - Data management lead for studies; providing guidance for other data managers on the team, coordinating data processing activities, ensuring clinical databases are correct, delivered on time and budget, and are of excellent quality. - Implement CDASH standards, produce and review CRF specifications following the CDASH implementation guide. - Work in a team for furthering data capture systems development. - Attend project teleconferences and ensure assigned actions are completed within the required timeframe. - Actively participate (including presentations) at project Kick Off meetings and Clinical Trial Team meetings for the assigned trials, ensuring appropriate level of support and communication provided. - Liaise with Study Statistician and Study Project Manager regarding resourcing, timelines, and deliverables. - Be point of contact for data management issues for the team across multiple studies. - Provide support for Data Safety Monitoring Board and all other vendors, including training of Investigators, site staff, and the client’s internal teams. - Work in a cross-functional team environment in experience-appropriate studies; identifying issues, giving solutions, and advising on cross-functional issues throughout study conduct. - Ensure effective communication between functional teams and with the client, providing a high level of client satisfaction through successful execution of projects. Qualifications - Experience working within a clinical trials environment (CRO, pharma or academia). - Previous experience in Medidata Rave. - Experience in CDISC. Benefits - Remote working and flexible working hours. - Career development, mentorship, and continuous learning. - Supportive, friendly, and collaborative culture. - Making a Positive Impact: As a B-Corp™ organization, we are committed to sustainability, solid responsibility and strong ethical governance through our ESG initiatives.

• Focus on supporting one of our key pharmaceutical clients within our FSP function • Hands-on technical role with oversight responsibilities • Cross functional exposure

• Work as an experienced programmer across multiple clinical studies • Support regulatory submission activities • Produce and validate datasets and outputs • Program and validate datasets and SDTMs • Program complex non-efficacy outputs/figures • Perform Senior Review and Deliver QC of non-statistical output • Coordinate and perform code reviews • Create, QC and update complex dataset specifications • Act as a Lead programmer on multiple studies and projects • Develop archiving systems and processes

Role Description As a Senior Statistician you will support one of our key pharmaceutical clients within our FSP function and will concentrate on oncology studies. This will be a hands-on technical role which may provide lead opportunities, if desired. This role will be full time and permanent and can be remote or hybrid (depending on the successful candidate's location). Should the successful candidate be based in the UK/EU, they must be located in one of the following countries: - Scotland - England - Northern Ireland - Wales - France - Spain - Poland The following areas of expertise will be aligned to the role: - Statistical expertise and scientific leadership - Leadership and people development - Compliance, quality and governance - Communication and influence Qualifications - Educated to PhD or MSc in Biostatistics, statistics or a related discipline - 5+ years experience working with a CRO environment or pharmaceutical company - 2-3+ years of oncology experience - Experience with solid tumor efficacy QC (familiarity with RECIST, time to event endpoints, etc) - 5+ years of CDISC experience - Good programming skills in SAS/R - Experience in drafting/reviewing stats or data management documents (advantageous) - Able to work independently, but also be a strong team player Benefits - Remote working and flexible working hours - Career development, mentorship, and continuous learning - Supportive, friendly, and collaborative culture - Making a Positive Impact: As a B-Corp™ organization, we are committed to sustainability, solid responsibility and strong ethical governance through our ESG initiatives Company Description 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

• As a Senior Statistical Programmer, you will be working embedded within the sponsor FSP team. • This role will be using both SAS & R Programming within the clinical domain. • Program and validate datasets and SDTMs, including complex efficacy, labs, etc. • Adhere to client SOPs and work on client systems • Oversight of Vendor Programming • Knowledge of FDA CRT requirements including define.xml • Lead Team and be responsible for creation of CRT packages • Perform R Programming on Datasets • Program complex non efficacy outputs and figures • Perform senior review and deliver QC of non-statistical output • Create, QC and update complex dataset specifications

• Lead late phase, non-interventional, observational and medical studies • Transform clinical and Real World Data (RWD) into analysis read datasets • Generate Tables, Listings and Figures (TLF) • Ensure analysis is reliable and accurate to support publications, submissions and medical insights • Work cross-functionally along side the Medical Affairs team • Programming SDTM and ADaM datasets and working within CDISC standards • Utilize R Shiny and Python to visualize data • Clean and manage datasets to maintain compliance and accuracy

• Work as a principal programmer across multiple clinical and non-clinical studies • 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) • Ensuring the principles in the PHASTAR checklist are followed rigorously • Act as a Lead programmer on multiple studies and project, ensuring quality and timely delivery

• Program and validate datasets and SDTMs, including complex efficacy, labs, etc. • Program complex non efficacy outputs/ figures • Perform Senior Review and Deliver QC of non- statistical output • Develop and debug complex macros • Become involved in developing the standard macro library and take responsibility to implement standard macros within a study • Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc • Review more complex 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 • Lead a team for furthering programming development • Ensure the principles in the PHASTAR checklist are followed rigorously • Archive study documentation following instructions in supplied SOPs • Act as a Lead programmer on multiple studies under same 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 • Create, review and update processes and SOPs • Take responsibility for study compliance with SOPs and processes

• Work as a senior programmer on clinical and non-clinical trials; producing complex datasets and outputs to excellent quality whilst adhering to deliverable timelines. • 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 • Responsible for study level resources • Point of contact for programming issues for the team, proactively ensuring everything is working cohesively