Biostatistical Programming Senior Manager

Biostatistical Programming Senior Manager

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically accurate. The Biostatistical Programming Senior Manager (Product Lead Programmer) will lead or co-lead a group of products within or across therapeutic areas. This Senior Manager will be accountable and responsible for Global Statistical Programming study results and submission activities for the assigned product areas.

• Accountable and responsible for ensuring successful execution and delivery of Global Statistical Programming (GSP) milestone analysis deliverables and regulatory submission packages for a group of Amgen products being supported by offshore programmers.
• Working with global PLPs, ensure successful implementation of the programming strategies such as functional standards and industry requirements for the assigned product areas globally.
• Plan and monitor progress of projects and address issues accordingly.
• Provide GSP product level input to developing and managing resource plans and budgets for GSP.
• Efficiently and effectively monitor and utilize assigned staff at product level according to priorities.
• Lead and/or participate in departmental process improvement initiatives and cross-functional working groups.
• Assist in study and system audits and inspections by internal and external bodies.
• Develop, review, and implement Policies, SOPs and other controlled documents affecting GSP globally.
• Provide hands-on support to the assigned product areas as required.
• Provide coaching and mentoring to offshore programming staff.
• Provide input into career development plans for all staff on assigned projects.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Biostatistical Programming Senior Manager we seek is a leader with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of statistical programming in Pharmaceutical industry experience OR
• Master’s degree and 6 years of statistical programming in Pharmaceutical industry experience OR
• Bachelor’s degree and 8 years of statistical programming in Pharmaceutical industry experience

Preferred Qualifications:

• Strong technical, communication, and leadership skills
• Experience developing a successful offshore statistical programming team
• Flexibility and desire to work across different time-zones  
• In depth knowledge of SAS Graph, SAS STAT, SAS Macro and SQL
• Advanced SAS analysis and reporting skills
• Prior regulatory submission experience
• Thorough understanding and experience with data quality and compliance checks
• Experience in software development (e.g., gathering user requirements, creating technical specifications, developing code, creating, and driving test plans).
• Familiar with R Programming language
• Statistical programming experience in a clinical development environment
• Experience working effectively in a globally dispersed team environment with cross-cultural partners
• Ability to lead and manage programmers in the successful and timely completion of all programming activities for a study or multiple studies from end to end
• Prior staff development leadership and project management experience
• Excellent oral and written communication skills
• Ability to effectively perform complex statistical programming and related tasks