Senior Statistical Programmer I/II

at  Phastar

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.

Qualifications:

• BSc, MSc or PhD in Mathematics, Science or IT related discipline
• 6+ years experience working within a clinical trials environment i.e. within a CRO, pharma or academic setting (essential)
• 5+ years of SAS programming experience (essential)
• 5+ years of CDISC (SDTM and ADaM) experience
• Knowledge of FDA CRT requirements including define.xml and define.pdf
• Previous experience of leading teams is preferred but not essential
• Excellent written and verbal communication skill

Demand for our Functional Service Provision is growing. We are therefore looking for an experienced, ambitious and driven Statistical Programmer to join our FSP team at Senior I or Senior II level. This role involves supporting one of our fantastic pharmaceutical clients in the US on remote basis and will focus on late phase GI studies.
As an FSP Senior Statistical Programmer I/II you will hold a 100% hands-on technical programming role and will be a key member of the FSP team. This is an excellent opportunity to work for a growing CRO that is recognized for its continuous learning and development opportunities, whilst also gaining direct experience of working within a pharmaceutical environment.

Responsibilities:

• Manipulation of data to produce analysis datasets, including SDTM and ADaM datasets
• Production and review of Tables, Figures and Listings (TFLs) according to statistical analysis plan
• Creation and review of programming specifications and, if required, annotation of case report forms (CRFs) to CDISC standards
• Program complex non efficacy outputs/ figures
• Develop and debug complex macros
• Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies
• Review simple study design SAP without supervision
• Review all shells without supervision and provide feedback
• Feeding back data errors to client data management teams
• Assisting internal management team in assessing resourcing needs for successful completion of assigned projects
• Working to industry (CDISC) and client standards
• Working specifically on late phase GI studies

Qualifications:

• BSc, MSc or PhD in Mathematics, Science or IT related discipline
• 6+ years experience working within a clinical trials environment i.e. within a CRO, pharma or academic setting (essential)
• 5+ years of SAS programming experience (essential)
• 5+ years of CDISC (SDTM and ADaM) experience
• Knowledge of FDA CRT requirements including define.xml and define.pdf
• Previous experience of leading teams is preferred but not essential
• Excellent written and verbal communication skills