Biostats Sr. Manager

Job Description

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:

• 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.

BASICQUALIFICATIONS

Doctorate degree and 2 years of experience OR Masters degree and 6 years of experience OR Bachelors degree and 8 years of experience OR Associates degree and 10 years of experienceOR High school diploma / GED and 12 years of experience

PREFERRED QUALIFICATIUONS

• Doctorate degree in biostatistics and at least 4 years of post-graduate statistical experience in the pharmaceutical industry or medical research Or
• Masters degree in biostatistics and at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research .
• Life Cycle Drug Development Experience (Pre-clinical Development, Clinical Development, and Post-marketing)
• Strong verbal and written communication combined with organizational skills and cross-cultural sensitivity
• Statistical leadership and contribution to regulatory and reimbursement submissions. of regulatory guidelines.
• Experience working effectively in a globally dispersed team environment with cross-cultural partners.

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.

• 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

APPLY NOW FOR A CAREER THAT DEFIES IMAGINATION

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

CAREERS.AMGEN.COM

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

Join Us

If youre 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, youll 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