Biostatistical Programming Manager
HOW MIGHT YOU DEFY IMAGINATION?
You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Biostatistical Programming Manager
What you will do
Let's do this. Let's change the world. In this vital role you will be responsible for the oversight of our Functional Services Provider (FSP) focusing on operational excellence and delivering projects on time to the expected levels of high quality and compliance. You will oversee the execution and quality of projects managed by FSP and ensure that projects are prioritized according to the product strategy.
- Ensure FSP programming meets quality, compliance, timeliness, and productivity expectations
- Ensure FSP adheres to relevant Amgen Policies, SOPs and other controlled documents as per Statement of Work
- Align FSP assignments with Amgen Development priorities
- Provide guidance to FSP Study Lead Programmers (SLP) on Amgen Global Statistical Programming (GSP) processes, tools, and utilities
- Contribute to FSP on-boarding training material development and revisions, and support the initial training of FSP staff and contribute to performance metrics data collection and reporting
Be part of our team
You would be joining the Global Statistical Programming team who serve patients by translating clinical study data into meaningful summaries to support high-quality submissions.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Biostatistical professional we seek is a proven leader with these qualifications.
- BS/BSC in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject
- At lease 6 years of statical experience in a biopharmaceutical industry
- Thorough understanding of clinical trial processes in the biopharmaceutical industry, 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 related 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 analytics and reporting skills including SAS Base, macro and SQL
- Hands on experience in specifying and implementing SDTM and ADaM data sets and TFLs
- MSc in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject
- Regulatory submission experience
- Vendor and resource management experience
- Familiarity with other programming languages such as R or Python
- In-depth knowledge of SAS/Graph and Stat packages
- Thorough understanding of data compliance such as Pinnacle 21
- Thought leadership
- Ability to define and implement an effective standardization strategy for the product following the latest CDISC SDTM, ADaM and define standards
- General therapeutic area knowledge
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan-comprising health, finance and wealth, work/life balance, and career benefits-with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
Equal Opportunity Statement
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 a 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 an accommodation.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.