Biostatistical Programming Mgr
- Employer
- Amgen
- Location
- Washington D.C., District of Columbia
- Start date
- Sep 18, 2024
View more categoriesView less categories
- Discipline
- Information Technology, Science/R&D, Biostatistics
- Required Education
- High School or equivalent
- Position Type
- Full time
- Hotbed
- Best Places to Work
Job Details
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Biostatistical Programming ManagerLiveWhat you will do
Lets do this. Lets 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 Technical Manager will ensure that projects outsourced to our Functional Service Providers (FSPs) are aligned with our priorities and meet Amgen timeline, quality, data standards and compliance expectations. The Technical Manager will also provide technical consultancy to our FSPs on Amgen processes, tools and utilities.
Responsibilities:Oversee the execution and quality of projects managed by our FSPs per Amgen Global Statistical Programming (GSP) Quality Oversight Plan (QOP)
Align FSP assignments with Amgen Development prioritiesEnsure that FSP programming meets quality, compliance, timeline, and productivity expectations
Contribute to FSP training material development and revisions, and conducting the initial training to FSP staff
Provide guidance and technical consultancy to FSP Study Lead Programmers (SLP) on Amgen processes, tools, and utilities
Contribute to FSP performance metrics development, data collection, and reporting
Review project documentations such as specifications, issue logs, deliverable status for accuracy and completeness
Advise FSP SLP on study-specific questions for specifications, documentation, and coding
Lead/contribute to GSP continuous improvement initiatives
WinWhat we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is proficient with these qualifications.
Basic Qualifications:Doctorate degree OR
Masters degree and 2 years of statistical programming experience OR
Bachelors degree and 4 years ofstatistical programming experience OR
Associates degree and 8 years ofstatistical programming experience OR
High school diploma / GED and 10 years ofstatistical programming experience
MSc in Computer Science, Statistics, Mathematics, Life Sciences or another relevant scientific subject
Regulatory submission experienceVendor and resource management experience
Familiarity with other programming languages such as R or Python
In-depth knowledge of SAS/Graph and Stat packagesThorough understanding of data compliance checks such as Pinnacle 21
6+ years of statistical programming in biopharmaceutical industryThorough understanding of clinical trial processes from data collection to analysis reporting
Ability to lead programmers in successful completion of all study programming activities and provide guidance on technical and process questions
Experience working in a globally dispersed team on Phase 1-4 clinical trials
Excellent oral and written English communication skills; strong negotiation skills
Advanced SAS analysis and reporting skills including SAS Base, macro, and SQL
Hands-on experience in specifying and implementing SDTM and ADaM data sets and TFLs
ThriveWhat you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.comAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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