BACKGROUND

When Amgen was founded in 1980, the company consisted of a few scientists working on a single lab bench in one building. Today, we are the world’s largest biotechnology company, with approximately 14,000 staff members worldwide – and growing.

Amgen has pioneered the development of novel products based on advances in recombinant DNA and molecular biology and launched the biotechnology industry’s first blockbusters. To sustain our success, we aim to attract and retain the most talented people who are dedicated to our mission of serving patients. Together, we live the Amgen values as we create innovative, best-in-class therapeutics that dramatically improve people’s lives.

RESPONSIBILITIES

The Biostatistical Program Manager will represent the programming function and participate in technical programming and process improvement initiatives within Global Biostatistics. They will also promote and communicate awareness of biostatistical programming and the role of the Biostatistics department. Provide support to and mentor more junior programmers. Additionally, they will ensure all programming activities adhere to department standards as well as resource and timeline plans. Draft programming plans or review and approve those drafted by another programmer. Create or review and approve all programming plans at study and program level. Draft SDF dataset specifications or review and approve those drafted by another programmer. Write, test, and validate software programs to produce SDF and analysis datasets and TLGs for inclusion within CSRs, ISS/ISE, publications and other communications.

Review and approve key study-related documents produced by other functions (e.g. CRF, Data Management Plan, etc.). Perform QC checking of software programs written by another programmer. Manage software development, testing & release in a Unix environment. Write, test, validate and executive department level, program level, and study level macros and utilities. Review SAPs from the programming perspective. Generate randomization lists.

Contribute to RFPs for programming services from outsourcing vendors. Oversee work of outsourcing partners and vendors at study level.

Participate in the development and review of Amgen Policies, SOPs and other controlled documents. Participate in study and systems audits by Amgen CQA and external bodies, and respond to audit questions and findings.

Working in the Center of Excellence for the Creation of Submission Data Files at Amgen, this role's responsibilities include, but are not limited to, the following:

'CDISC Implementation Expert and Mentor (Training Provided)
'Developing Submission Data File (SDF) Programs using Amgen's SDF System

The candidate will have clinical trials experience within the pharmaceutical, biotechnology and/or public health setting across industry, government or academia. The candidate should also have experience in drug development (pre-clinical development, clinical development, medical affairs), project planning/management, and development of policies and SOPs.

The successful candidate will have:

'Strong background in the implementation and use of Programming Standards
'Proven track record in the development and implementation of systems, tools and utilities to help standardize programming activities
'Excellent communication and Project Management skills
'Experience of a full Software Development Lifecycle (SDLC)

REQUIREMENTS

BS/BSc or higher degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject. At least five years of relevant experience in Biostatistical programming for drug development using the SAS System.

PREFERENCES

Candidates must live/relocate to the Seattle, Washington area

TERMS

Fulltime employment with Amgen

LOCALE

Seattle, Washington 98119

COMPENSATION

DOE, Full benefits

HOW TO APPLY

Candidates please apply through the Amgen Career Center:
Req: amge-00024370
Link: http://www.amgen.com/careers

DEADLINE

Position posted 1/22/07 - asap