Statistical Programmer (m/f)

REFERENCE NUMBER:

379050/14

MY DUTIES:

-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 GSS and groups outside of GSS (Clinical Data Operations, Technology and Standards (CDOTS), Global Medical Writing, New Medicines, Global Clinical Project Management, therapy areas, 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 internal 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 GSS 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.
-Supports development and rollout of new standards and processes with respect to own statistical programming operations team.
-Ensures compliance with the 21-CFR Part 11 regulations in terms of validation of SAS

MY QUALIFICATIONS:

-Bachelor or higher degree
-Deep knowledge in statistical programming within the Biotechnology and/or Pharmaceutical Industry (including clinical research organizations).
-Advanced SAS Software Programming skills, including experience with advanced DATA step, SQL and macro development to solve complex programming tasks.
-Experience with statistical programming aspects required for regulatory submissions.
-Advanced knowledge of SDTM and ADaM programming requirements and practices. Ability to define and implement new SDTM and ADaM domains into clinical studies practices.

MY BENEFITS:

-Home Office

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

MY CONTACT AT HAYS:

My contact person
Felix Czekalla

Reference number
379050/14

Contact
E-Mail: [email protected]