Statistical Programmer
Found in: Whatjobs IN C2 - 2 weeks ago
JOB DESCRIPTION :
1 Brief description of the job
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.
2 Description of tasks and responsibilities in each field
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 Reviewers 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)
Please use the below link for job application and quicker response.
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