Lead Statistical Programmer: Biotech : CDISC : SAS ADAM SDTM
The lead statistical programmer is responsible for ensuring quality and proactive technical clinical trial development working at a high statistical level alongside the therapeutic heads of biostatistics.
This position will also include working cross functionally and managing resource via vendors and CROs making your ability to maximize communication, externally and be confident with executing an outsourced model to ensure timelines, budgets and best proactive are met an executed in with internal agreements and CDISC standards.
Working on the company's pivotal trials across phases 1 - 4 you will be working with your designated CRO vendor and internal statistical programming team to ensure the Biostatistics team is fully supported.
Coordinating complex programming aspects requiring complex data manipulation and analysis.
Responsibilities will include:
Writing validation programmers for tables listings, figures and data sets
Create validate, maintain, store, and distribute global macros to streamline repetitive an clinical operations with the view of maximizing clinical trial productivity.
Create complex data set specifications and CDISC standards from raw data sets .
Develop and lead statistical programming Electronic Submission deliverables
Support Data Monitoring Committees
Lead process improvement teams
Work across up to 3 therapeutic areas
6 - 10 + years experience with Statistical (SAS) programming
Educated within a Statistical disipline (Statistics, Mathematics or Biostatistics)
CDISC from raw data assets
SAS/ MACRO, SAS/GRAPH, SAS/STAT, SAS/CONNECT
CDISC (SDTM and ADaM)
Excellent knowledge of Regulatory guidelines. Expert knowledge of Clinical trial statistical operations and standards required cross functionally across a the biotech business
To find out more about Real, please visit www.realstaffing.com