Head Of Programming

The Head of Statistical Programming management will manages individual contributors, vendors, and projects. You will also provides guidance to subordinates to achieve goals in accordance with established policies, ensure the group follows defined practices and policies in selecting methods and techniques for obtaining solutions.

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Develop and implement improved programming processes and methods
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Manage department quality requirements in coordination with Regulatory Compliance and IT.
* Collaborate with functional management across the organization on project deliverables and timelines for projects within area of responsibility.
* Manage group of internal programmers, consultant programmers, and CROs.
* Collaborate with other Biometrics functions for all activities related to analyses
* Responsible for execution of ad hoc requests, manuscripts, and presentations.
* Oversee all programming activities for a clinical program
* Oversee the preparation and review of programming deliverables for clinical study reports and scientific presentations; participate in team review of documents.
* Determine documentation and archival standards of statistical programming deliverables including analysis databases, summaries, programs, and specifications.
* Support major reporting deliverables and milestones for regulatory submissions.
* Performs project management for programming deliverables in a project..
* Establish and negotiate timelines with internal team members for completion of activities
* Train and manage employees and consultants within area of responsibility.
* Responsible for budget and resource planning for statistical area.

Requirements

* A minimum of 5 years of SAS programming experience in the pharmaceutical or biotechnology industry with a BA/BS, or MA/MS with 4 years of experience.
* BS/BA in Statistics, Computer Sciences, Mathematics, Life Sciences; MA/MS preferred.
* Experience in the management of people and projects
* Experience in working in and contributing to cross-functional teams
* Proven track record in forming and managing a functional team to support multiple projects.
* Experience as a senior statistical programmer level in a pharmaceutical or CRO working in a FDA regulated environment.
* Experience with Clinical Study Reports and NDA submissions.
* Oncology experience preferred.To find out more about Real Staffing please visit www.realstaffing.com