Statistical Programming Associate Director

Location North Carolina
Discipline: Biometrics
Job type: Permanent
Salary: £135000 to £150000
Contact name: Dan Sidell

Contact email: dan.sidell@rbwconsulting.com
Contact phone: (617) 982 1238
Job ref: 22106
Published: 20 days ago
Expiry date: 07 October 2021

We currently have an extremely exciting opportunity with a leading Biopharmaceutical company for a Statistical Programming Associate Director role working in their Respiratory and Immunology department.

This programming group has direct impact on their large-scale drug development and gives the chance for widespread patient impact. This role can be open to multiple east coast locations, and you will be a part of a global team which is driving innovation.

Position Summary:

The candidate will lead and assist in programming activities for the analysis and reporting process, including Clinical study report development, regulatory submissions, scientific utilization of the data, and more.

Responsibilities:

You will be reporting to the Director of programming to lead, assist, and provide expertise in the following areas:

-          Responsible for the delivery of the Clinical Study Report and Study/Analysis Data TFL’s.

-          Provide statistical programming deliverables for regulatory submissions.

-          Produce and maintain technical database standards.

-          Develop Safety Update reports, benefit risk evaluations, and investigator reports.

-          Plan and communicate the analysis of data to Safety monitoring boards and independent monitoring committees.

Requirements:

-BSc or higher is Statistical, Mathematical, Computer science, or Life Science related fields.

-Exceptional problem-solving skills and organization/attention to detail

-Extensive SAS experience within a Clinical Development or Healthcare organization at an advanced level

-Submission Experience along with Technical and regulatory expertise

-Extensive knowledge of CDISC standards