- Support biostatistical activities for Clinical Development, Clinical Operations, Medical Affairs, and Business Development
- Provide statistical expertise and leadership to ensure program objectives are in alignment with regulatory and commercial needs
- Serve as primary author for statistical sections of protocol
- Create accompanying statistical documents (e.g., statistical analysis plan and mocked shells)
- Participate in development of EDC database and interactive response technology (IxRS) specifications
- Collaborate with project management, regulatory, medical affairs, PV/safety, business development, and commercial functions
- Implement innovative statistical techniques that will provide benefit to clinical development programs
- Contribute to strategic planning and go/no go decision guidance
- Review biostatistics and statistical programming tasks outsourced to vendors
- Perform statistical analyses and create statistical text for clinical publications and other communications, perform SAS programming validation if needed
- Support the preparation of regulatory submissions documents including summaries of clinical safety and efficacy of BLA/NDAs if needed
- Ensure timeliness and quality of deliverables
- Travel as needed to execute assigned responsibilities.
- PhD in statistics or related field and at least 4 years of industry experience or MS in statistics or related field and at least 6 years of industry experience
- Comprehensive knowledge of clinical trials methodology, regulatory requirements, and proficient SAS programming skills and experience with other statistical software packages. Ability to contribute strategically
- Proficient in Microsoft Office
- Professional, proactive demeanor
- Excellent written and verbal communication skills
- Experience with people management and development of staff
- Excellent interpersonal and project management skills
- Able to collaborate effectively with internal and external study management teams to meet project timelines
- Must be solution-oriented and willing to educate study team members in appropriate interpretation of designs and results
- Vast opportunities to learn and move up and across our global organization
- 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
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Biostatistics Sr Manager - Rockville, United States - Amgen
Description
JOB ID:
R LOCATION:
US - Maryland - Rockville
ADDITIONAL
LOCATIONS:
United States - Remote
WORK LOCATION TYPE:
Remote
DATE POSTED:
Mar
04, 2024 CATEGORY:
Clinical
SALARY RANGE:
157,846.00 USD - 184,097.00 USD
Position Summary:
The primary role of this position is to provide statistical support for multiple clinical studies across all phases of clinical development.
Apply statistical principles and techniques to a wide range of problems within the clinical development environment with the supervision of more senior staff.
Responsibilities:
BASICQUALIFICATIONS
Doctorate degree and 2 years of experience OR Master's degree and 6 years of experience OR Bachelor's degree and 8 years of experience OR Associate's degree and 10 years of experience OR High school diploma / GED and 12 years of experience
PREFERRED QUALIFICATIUONS
WHAT YOU CAN EXPECT OF US
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.
APPLYNOWFOR A CAREERTHATDEFIESIMAGINATION
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt.
CAREERS.AMGEN.COM
EqualOpportunityStatement
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.
Join Us
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.
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 whorespect 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
Apply Now
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