Phastar · 3 months ago
Principal Programmer Oncology
United States
Full-time
Remote
Lead/StaffPhastar is a company focused on statistical programming within the pharmaceutical industry, seeking a Principal Programmer to work across multiple clinical and non-clinical studies. The role involves supporting regulatory submissions, producing and validating datasets, and ensuring high-quality outputs while adhering to timelines.
BiotechnologyBig DataLife ScienceMedical DevicePharmaceuticalData Management
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, 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
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
Take responsibility for study compliance with SOPs and processes
Qualification
Required
Educated to BSc or above within Computer Science, Mathematics or a Science related discipline
SAS Programming Experience within the pharmaceutical industry and experience on Oncology Therapeutic Study
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
Company
Phastar
Phastar is specialist biometrics CRO, offering statistical consulting, clinical trial reporting, data science and data management services.
Founded in 2007
501-1000 employees
H1B Sponsorship
Phastar has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
100%
Represents job field similar to this job
Engineering and Development
Trends of Total Sponsorships
*2026 (1)
2023 (1)
2022 (1)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Charterhouse Capital Partners
2021-01-05Private Equity
Leadership Team
April Romano
Senior Human Resources Business Partner
Chuck Gelb
Chief Commercial Officer
Recent News
2025-05-17
2025-02-13
Company data provided by crunchbase