Biostatistical Programming Manager

Amgen

(Washington, District of Columbia)

Full Time

Job Posting Details

About Amgen

Amgen is one of the world’s leading biotechnology companies. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.

Responsibilities

- Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications 
- Efficiently manage project team resources and timelines 
- Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, NONMEM specifications, etc. 
- Write, and/or review and approve programming plans 
- Write, and/or review and approve analysis dataset specifications 
- Lead a complicated study, or lead multiple studies, with minimum supervision. 
- Represent the programming function and participate in multidisciplinary team meetings 
- Contribute to the continuous improvement of programming, Global Biomedical Data Sciences (GBS), and Research and Development (R&D) 
- Write, test and validate department-, product- and protocol-level macros and utilities 
- Participate in the development and review of GBS Policies, SOPs and other controlled documents 
- Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings 
- Interview potential programming candidates 
- Actively participate in external professional organizations, conferences and/or meetings 
- Provide input to and participate in intra-departmental and GBS meetings 
- Support and mentor junior programmers

Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications
Efficiently manage project team resources and timelines
Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, NONMEM specifications, etc.
Write, and/or review and approve programming plans
Write, and/or review and approve analysis dataset specifications
Lead a complicated study, or lead multiple studies, with minimum supervision.
Represent the programming function and participate in multidisciplinary team meetings
Contribute to the continuous improvement of programming, Global Biomedical Data Sciences (GBS), and Research and Development (R&D)
Write, test and validate department-, product- and protocol-level macros and utilities
Participate in the development and review of GBS Policies, SOPs and other controlled documents
Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings
Interview potential programming candidates
Actively participate in external professional organizations, conferences and/or meetings
Provide input to and participate in intra-departmental and GBS meetings
Support and mentor junior programmers

Ideal Candidate

- Bachelors or Masters degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject 
- For therapeutic area support, six (6) years clinical research and development programming experience 
- For system and process support, six (6) years project management and software application development experience 
- Drug Development (pre-, early, late and/or observational) in related industries or academic research 
- Project planning 
- Process improvement participation 
- International co-operation 
- Team participation and effectiveness 
- Advanced CDISC knowledge and implementation experience 
Knowledge 
- Computer programming, preferably SAS or other procedural languages 
- Understanding of computer operating systems, UNIX preferred 
- Biostatistical Programming within Drug Development 
- Drug Development Process & Operations 
Key Competencies 
- Scientific / Technical Excellence 
- Project Management 
- Team Work 
- Problem Solving 
- Attention to Detail 
- Oral and Written Communication

Bachelors or Masters degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject
For therapeutic area support, six (6) years clinical research and development programming experience
For system and process support, six (6) years project management and software application development experience
Drug Development (pre-, early, late and/or observational) in related industries or academic research
Project planning
Process improvement participation
International co-operation
Team participation and effectiveness
Advanced CDISC knowledge and implementation experience Knowledge
Computer programming, preferably SAS or other procedural languages
Understanding of computer operating systems, UNIX preferred
Biostatistical Programming within Drug Development
Drug Development Process & Operations Key Competencies
Scientific / Technical Excellence
Project Management
Team Work
Problem Solving
Attention to Detail
Oral and Written Communication