Statistical Programmer

Job Title

Responsibilities:

Develop SAS programs and statistical output for the management and reporting of clinical trial data managed by GCD

Guarantee quality of statistical output produced by external provider, to program tools to support data review activities and data visualization, to collaborate on the interpretation and communication of trial results

Contribute to regulatory submissions, converting data according to regulatory requirements, preparing integrated analyses and related documentation

Perform post-hoc analysis for exploratory purposes, or to support regulatory requests, to prepare analysis for paper publications

Support the development of standard operating procedures

To convert data to CDISC SDTM, following project specifications

Develop SAS programs to generate analysis datasets (CDISC compliant)

Produce datasets documentation according to CDISC and FDA requirements (define.xml) and/or to review analysis datasets documentation prepared by providers

Develop SAS programs to produce tables, listings, and figures as planned in the statistical analysis plan and to support data review activity before database lock

Develop SAS macros and SAS programs for data quality evaluation and to develop data quality reports

Writing, documenting, and performing quality control review of SAS programs

Perform ad hoc analysis for various statisticians' requirements

Support statisticians in the preparation and/or review and QC of statistical package for FDA submissions

Perform QC of the programming material prepared by external providers guaranteeing the output provided is correct and in line with International requirements and with internal SOP/Standards

Requirements:

Bachelor's degree or higher, preferably in a scientific discipline such as Statistics, Mathematics, Computer Science, or a related applicable field

Good experience in SAS

Proficient in Macro Facility

Extensively involved in clinical data analysis and preparation of SAS Data sets, Reports, Tables, Listings, Summaries and Graphs according to Standard Operating Procedures (SOPs)

Knowledge of Clinical Data Interchange Standards Consortium (CDISC) relating to data standards including Study Data Tabulation Model (SDTM), Analysis Dataset Models (ADaM), Operational Data Model (ODM) and Case Report Tabulation Data Definition Specification (Define.xml)

General knowledge of statistical methods

Have excellent analytical, problem solving, communication and interpersonal skills

Effective verbal and written communication skills

Strong commitment to quality

Ability to work in a team-based environment.