Principal Statistical Programmer

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Job description

RBW consulting is currently recruiting for a Principal Statistical Programmer on a permanent basis working remotely in either the UK, Belgium or Germany.

The successful candidate will join a global biopharmaceutical company who strive to make the lives of people living with severe diseases that much more manageable. They continue to grow and keep their focus on the people they helping as their core value. They endeavour to deliver modern medicines and solutions that improve lives, whilst still being mindful of value.

Due to continuing growth, I am seeking additional innovative minds to join my clients Statistical Programming department to help shape the future.

You will be given access to cutting-edge in-house technology, allowing you to work on global projects across a variety of therapeutic areas. You will be able to progress your career in the direction you choose to go and will encourage and mentor you along the way.

*Responsibilities:*

* Leads and supports statistical programming activities for assigned clinical studies, submissions and development initiatives. Coordinates and provides input for assigned project and study teams on timelines and work product required to deliver high quality statistical programming services in close collaboration with CROs.

* Provides a high level of effective collaboration for statistical programming initiatives with key team members within SSI and groups outside of SSI (Clinical Data Operations, Technology and Standards (CDOTS), Global Medical Writing, New Medicines, Global Clinical Project Management, therapy areas, Quantitative Clinical Pharmacology, Marketing & Market Access and Global Clinical Development & Medical Affairs) to facilitate understanding of statistical programming services and work product.

* May program, validate, maintain, and document statistical analysis programs for asset development on the basis of the SAP and of other documents (Protocol, CRF, DMM, ISAP, DAP and ASD) following standard operating procedures and working documents.

* Where applicable, develops innovative programming methodologies (i.e. interactive visualization, dashboards, etc.) to facilitate easier interpretation by customer base

* Ensures that submission and study datasets (SDTM and ADaM), tables, figures, listings, statistical output, and program documentation meet standards requirements of regulatory agencies and other departments.

* Ensures that datasets, tables, figures, listings, and statistical outputs are produced in an efficient manner, following SSI procedures and standards. Develops specification documentation for datasets (SDTM and ADaM), pooled datasets, tables, figures, listings, and associated metadata.

* Supports direction, motivation, and oversight of statistical programming resources (internal and external) for timely delivery of all statistical programming outputs. Mentors and trains other statistical programmers as needed.

* Ensures compliance with the 21-CFR Part 11 regulations in terms of validation of SAS programs used for statistical reporting of clinical studies.

*Ideal Candidate *

* Proven track record in statistical programming within the Biotechnology and/or Pharmaceutical Industry (including clinical research organizations) with proven successful track record in pharmaceutical development.

* Excellent understanding and profound knowledge of statistical programming aspects required for regulatory submissions.

* Expert SAS Software Programming skills, including experience with advanced DATA step, SQL and macro development to solve complex programming tasks and/or expert in other programming languages like R, or Python. Experience in Data Visualization would also be advantageous.

* Advanced clinical studies design and analysis experience.

* Advanced knowledge of statistical principles.

Good leadership abilities and interpersonal skills to mentor and lead statistical programmers to successfully deliver high quality project, study team statistical programming work product and oversee CRO statistical programming teams

To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Ashley Clarke on (0) and send your CV through using the apply button on this page.