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Senior Statistical Programmer

3 months ago


Newcastle upon Tyne, United Kingdom Worldwide Clinical Trials Full time

Who we are

Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.

Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us

What Global Programming does at Worldwide

As the Lead Statistical Programmer on a project – you will be working directly with statisticians, sponsors, the wider study team and your own team of programmers, ensuring the data and output delivered for a study meets industry, regulatory submission and quality standards. Being an expert programmer remains a core to the role. As a Statistical Programmer at Worldwide, your analytical skills and ability to both program and understand / interpret data are the keys to success, and you will have the opportunity to continually grow your knowledge in SAS and CDISC across all phases and multiple therapy areas.

What you will do

  • Develop, test and execute SAS programs to produce and validate CDISC SDTM and ADaM datasets, tables, figures and listings (TFL).
  • Perform review and provide guidance on the development of the clinical database specification, data transfer agreement/specification, specification of tables, figures and listings (TFL) shells.
  • Develop and review specification for SDTM datasets and ADaM datasets for safety data, TFL shells and other specifications, e.g. patient profiles, OPS reports.
  • Develop and review electronic data submission package (SDTM annotated CRF, define.xml, Study/Analysis Data Reviewer's Guide) for high complexity studies.

What you will bring to the role

  • Must be computer literate and numerate with a willingness to adapt to various computer systems.
  • Hands-on expert level project statistical programmer experienced in providing programming leadership to projects.
  • Statistical programming skills and knowledge across a broad range of applications together with key competencies in customer focus, delivering on commitments, building strong relationships, communicating and influencing, and embracing innovation and change.

Your experience

  • Educated to degree level or equivalent.
  • Advanced SAS programming skills with expert knowledge in SAS/Macro, Proc Report and ODS. Good working knowledge in SAS/Graph, Proc SQL, SAS/STAT.

Why Worldwide

We love knowing that someone is going to have a better life because of the work we do.

To view our other roles, check out our careers page at www.worldwide.com/careers For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

Internal Description:

What Global Programming does at Worldwide

The Worldwide team is an experienced and diverse group of Programmers who collaborate together as one, both via regularly scheduled group meetings to discuss issues, and impromptu one-on-one discussions between colleagues to discuss a particular topic.

As the Lead Statistical Programmer on a project – you will be working directly with statisticians, sponsors, the wider study team and your own team of programmers, ensuring the data and output delivered for a study meets industry, regulatory submission and quality standards. Being an expert programmer remains a core to the role. As a Statistical Programmer at Worldwide, your analytical skills and ability to both program and understand / interpret data are the keys to success, and you will have the opportunity to continually grow your knowledge in SAS and CDISC across all phases and multiple therapy areas.

What you will do

  • Develop, test and execute SAS programs to produce and validate CDISC SDTM and ADaM datasets, tables, figures and listings (TFL).
  • Perform review and provide guidance on the development of the clinical database specification, data transfer agreement/specification, specification of tables, figures and listings (TFL) shells.
  • Develop and review specification for SDTM datasets and ADaM datasets for safety data, TFL shells and other specifications, e.g. patient profiles, OPS reports.
  • Develop and review electronic data submission package (SDTM annotated CRF, define.xml, Study/Analysis Data Reviewer's Guide) for high complexity studies.

What you will bring to the role

  • Must be computer literate and numerate with a willingness to adapt to various computer systems.
  • Hands-on expert level project statistical programmer experienced in providing programming leadership to projects.
  • Statistical programming skills and knowledge across a broad range of applications together with key competencies in customer focus, delivering on commitments, building strong relationships, communicating and influencing, and embracing innovation and change.

Your experience

  • Educated to degree level or equivalent.
  • Advanced SAS programming skills with expert knowledge in SAS/Macro, Proc Report and ODS. Good working knowledge in SAS/Graph, Proc SQL, SAS/STAT.