Statistical Programmer

3 weeks ago

Maidenhead, Windsor and Maidenhead, United Kingdom Pharmiweb Full time
Job Summary:

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, we provide pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, we are transforming drug and device development for partners and patients across the globe.

About the Role:

In this role, you will develop and validate SAS and R programs for data presentations and analyses, and provide programming support to your multidisciplinary global project team. You will be responsible for reviewing SAPs and TFL shells from a programming perspective, advising on the development of complex TFL shells, and developing and/or leading the development of complex specifications for SDTMs and ADaM datasets. Additionally, you will develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform quality control of SDTM, ADaMs and TFLs.

Responsibilities:

  • Review SAPs and TFL shells from a programming perspective
  • Advise on the development of complex TFL shells from a programming perspective
  • Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets
  • Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform quality control of SDTM, ADaMs and TFLs
  • Produce / define XML / PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs
  • Respond to QA and client audits and support qualification audits
  • Identify and propose innovative ways to improve the efficiency, quality and productivity of our clinical statistical programming business
  • Maintain awareness of industry standards, global regulatory requirements, internal guidelines and Standard Operating Procedures (SOPs)


Requirements:

  • Degree in a relevant field such as mathematics, life sciences, statistics, computer sciences, etc.
  • In lieu of the above: an equivalent completed vocational training and / or equivalent professional experience in statistical programming for clinical trials
  • Solid professional experience as a statistical programmer within a biotech, CRO or pharmaceutical company
  • Demonstrated knowledge of base SAS, SAS macros, SAS/STAT; demonstrated ability to debug SAS programs
  • Programming experience in R is required
  • Proven professional experience with SDTMs, ADaM datasets (safety and efficacy) and TFLs
  • Solid knowledge of CDISC standards
  • Strong organizational skills, an autonomous and collaborative work style, a curious mind and a keen attention to detail
  • Business fluency in English - both spoken and written - is a must


About Us:

We are a global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, we are transforming drug and device development for partners and patients across the globe. We are proud to be an Equal Opportunity Employer and strive for diversity and inclusion in the workforce. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.

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