Principal Statistical Programmer - SAS Immunomedics
Morris Plains, NJ

Job Description

Overview

We are seeking a Principal Statistical Programmer to provide statistical programming and analytic support clinical studies.

Responsibilities

This position will be responsible for SAS programming and statistical analytics for clinical studies.

* Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; system and database expertise.
* Creation and review of programming specifications.
* Creation of CDISC compliant SDTM and ADaM datasets, and development of data submission package including define.xml and data reviewers' guide
* Strong experience in statistical analysis methods and clinical data management concepts.
* Performing statistical analysis, generating analytic reports, Tables/Listings/Figures, and Ad-Hoc outputs in support Clinical Study report and exploratory analysis.
* Supervising junior programmers, managing programming vendors, and representing statistical programming group in project meetings

Qualifications

Requirements:

* Requires a Bachelor's or Master's degree or equivalent in Statistics, Applied Mathematics, Computer Science or related field.
* BS with 10+ years or MS with 8+ of work experience in pharmaceutical/biotech or related industry.
* Oncology or/and regulatory submission experience preferred.
* Solid programming background and advanced SAS programming skills required.
* Proven knowledge of clinical trials, CDISC standards, regulatory guidance, GCP.
* Must be able to work independently as well as part of a team.
* Must have good communication skill (verbal and written).