Senior Associate, Biostatistical Programming (Level 4)

Context and Responsibilities:

The Senior Associate, Biostatistical Programming :

Is a regional role within US or international GBDS

Reports to:

Director, Senior Manager or Manager within GBDS programming

Responsible for:

•Ensuring quality and accuracy of programming deliverables

•Adherence to Amgen Policies, SOPs and other controlled documents

•Mentor junior level programmers

Key Activities:

•Assist in the review of key study-related documents produced by other functions, e.g. case report form, data management plan, NONMEM specifications

•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

•Understand and execute department-, product- and study-level macros and utilities

•Write, test and validate product- and study-level macros and utilities

•Assist with study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings

•Provide input to and participate in intra-departmental and GBDS meetings

•Contribute to the continuous improvement of Global Biomedical Data Sciences (GBDS) and programming

•Assist in the review of GBDS policies, standard operating procedures and other controlled documents

•Provide support to and mentor more junior programmers

•Interface with outsourcing partners and vendors

•Attend external professional organizations, conferences, training and/or meetings

Basic Qualifications

•Bachelors degree

•Three (3) years clinical research and development programming experience

•Computer programming

Preferred Qualifications

•Bachelors or Masters degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject

•Four (4) years clinical research and development programming experience

•Drug Development (pre-, early, late and/or observational) in related industries or academic research

Knowledge

•Computer programming, preferably SAS or other procedural languages

•Understanding of computer operating systems, UNIX preferred

•Fundamentals of Project Planning and Management

•Drug Development Process & Operations

Key Competencies

•Scientific / Technical Excellence

•Problem Solving

•Team Work

•Attention to Detail

•Basic Project Management

•Oral and Written Communication