91 applicants

Company

Phastar · 4 days ago

Senior/ Principal Statistical Programmer - Submissions

United States

Full-time

Remote

Senior Level, Lead/Staff

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BiotechnologyData Management

Culture & Values

H1B Sponsor Likely

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Responsibilities

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

Qualification

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SAS ProgrammingCDISC KnowledgeSDTM StandardsADaM StandardsOncology ExperienceGCP FamiliarityClinical Trial DesignComputer Science DegreeMathematics DegreeScience Degree

Required

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.

Prior experience in Oncology is essential

Familiarity with GCP and regulatory requirements

Experience of programming to SDTM and ADaM standards

Benefits

Flexible working

Part-time hours

Involvement in developing company-wide initiatives

Structured training and development plans

A truly supportive, fun and friendly environment

Continuous learning opportunities

Competitive salary and benefits package

Company

Phastar

Phastar is specialist biometrics CRO, offering statistical consulting, clinical trial reporting, data science and data management services.

Founded in 2007

London, England, GBR

201-500 employees

https://phastar.com/

H1B Sponsorship

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Trends of Total Sponsorships

2022 (2)

2020 (1)