NOW HIRING! Associate Director, Statistical Programming in Woodcliff Lake, NJ
20th July, 2020
Job Type: Direct
The pharmaceutical industry is NJ's top industry and recession-proof. Very stable environment.
Our client is a premier, nationally recognized Pharmaceutical company looking to hire an Associate Director, Statistical Programming. The ideal candidate will spearhead the statistical programming activities for several studies as well as lead programming submission. The candidate will also collaborate with the Head of Programming to establish standards for programming.
Effectively design and develop SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS.
Develop and deliver CDISC and regulatory compliant SDTM, and ADaM standard datasets.
Develop and execute statistical analysis and reporting deliverables (tables, figures and listings (TFLs)) in a timely and high-quality manner.
Provide input in the design and development of case report forms and clinical study databases.
Collaborate with cross-functional teams to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, and product launch.
Drive and oversee Statistical Programming activities internally and externally (CRO), and act as project manager for statistical programming deliverables.
Assess and perform quality control checks/validation of SAS code and output produced by vendors or other Statistical Programmers for SDTM datasets, ADaM datasets, and TFLs.
Author and review SDTM and ADaM datasets specifications for datasets programming.
Create and review eCTD documents to support regulatory submission package.
Provide programming support for building integrated summary of safety/efficacy datasets and analysis.
Participate in the development and review of relevant SOPs.