Statistical Programmer

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.

Remote Work :

No