Senior Statistical Programmer (m/f) Job in Monheim am Rhein, Germany

Senior Statistical Programmer (m/f) Job Description

Our challenge. Your impact.  
We aspire to be the Patient Centric global biopharmaceutical leader transforming the lives of people with severe diseases and need exceptional individuals to achieve this goal. We are looking for enthusiastic and talented professionals who thrive on challenge and change, who want to make a difference and deliver results.  

• Based at our site in Monheim, Germany, you'll lead and support worldwide statistical programming activities for the assigned area within UCB, for clinical trials whose responsibility resides in Development.
• You'll also function as lead statistical programmer or support programmer with respect to all statistical programming activities for multiple clinical trials or submissions. 
• You’ll set-up and oversee a clinical project or trial, and provide programming support to enable delivery of high quality statistical programming work product. 
• You generate datasets (SDTM and ADaM) and tables, figures, listings, and documentation for clinical study reports, ad hoc requests, and regulatory submissions. 
• You'll produce submission ready electronic datasets, tables, figures, listings and documentation that support and match planned work product and are sufficient to respond quickly to questions by regulatory authorities.
• You will lead and support statistical programming activities for assigned clinical trials and support the global team of Statistical Programmers.  Coordinate and provide input for assigned project and trial teams on timelines and work product required to deliver high quality statistical programming services.
• You program, validate, maintain, and document statistical analysis programs for clinical trials on the basis of the Statistical Analysis Plan and of other trial documents (Protocol, CRF, DMM) following UCB standard operating procedures and working documents.
• You ensure that submission and trial datasets (SDTM and ADaM), tables, figures, listings, statistical output, and program documentation meet standards requirements of regulatory agencies and other departments within UCB
• You assist with developing specification documentation for datasets (SDTM and ADaM), pooled datasets, tables, figures, listings, and associated metadata.
• You’ll support direction, motivation, and oversight of statistical programming resources (internal and external) for timely delivery of all statistical programming deliverables. Mentor other statistical programmers as designated.
• Support development and rollout of new standards and processes with respect to own statistical programming operations team.

Senior Statistical Programmer (m/f) Job Requirements

Qualifications

• You should hold at least a Bachelor's degree and bring in at least 5 years in Statistical Programming within the Biotechnology and/or Pharmaceutical industry, including clinical research organizations. You'll bring at least 2 years experience in a global pharmaceutical environment and have experience with statistical programming aspects required for regulatory submissions.
• You have advanced SAS Software Programming skills, including experience with advanced DATA step, SQL and macro development to solve complex programming tasks.
• You are familiar with Advanced Clinical Trials Design and Analysis Expertise & Experience, including comprehensive understanding of drug Development Phases, Clinical Trials Designs, Efficacy Endpoints and Assessments and Safety Endpoints and Assessments.
• You have working knowledge of statistical principles, including descriptive and inferential statistical (parametric and non-parametric) methods.
• You have superior communication skills; a good command, both verbal and written, of English.
• You also have advanced problem solving skills and experience and bring the ability to identify and prevent programming problems appropriate to the role.

Senior Statistical Programmer (m/f) Application Information

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Senior Statistical Programmer (m/f) Summary

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