As a Clinical Statistical Programmer, you provide statistical programming expertise to deliver high

quality programs and outputs for analysis of clinical data. It is your responsibility to provide high

quality analysis results on time to support efficient decision making.

• Develop Analysis Data Model (ADaM) datasets

• Develop Tables, Figures and Listings / Output and Programming Specification (TFL/OPS) from the Statistical Analysis Plan (SAP) o r a related document

• Develop Define.xml and Analysis Data Reviewer’s Guide (ADRG) for data submission

• Program and validate standard ADaM and utility Statistical Analysis Software (SAS) macros or R function/package following good programming practices

• Act as a statistical programming representative within cross functional study teams and project sub teams and provide statistical support and solutions

• Provide input to internal process improvements and/or new statistical programming capabilities

• Maintain current scientific and regulatory knowledge

• Bsc. in Statistics, Mathematics, Informatics or equivalent

• At least 8 years of experience as a statistical programmer in the pharmaceutical industry

• Proficient in English (oral and written)

• Excellent programming skills in SAS (Macro, SQL) and R (function, package)

• Able to develop, validate and maintain programs

• Excellent understanding of the standardization and automatization processes

• Excellent knowledge of statistical concepts and statistics applied to non clinical, pre clinical and clinical data

• Excellent knowledge of GCP and ICH guidelines

• Excellent communication skills, able to build good relationships with internal and external stakeholders

• Team player, able to work in a multidisciplinary team

• Able to manage, drive and meet delivery timelines

• Excellent knowledge of CDISC standards (ADaM , SDTM)