Job Information
Amgen Biostatistics Senior Manager, Rare Disease in Washington D.C., District Of Columbia
Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Biostatistics Sr Manager
What you will do
Let’s do this. Let’s change the world. In this vital role you will 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.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of industry experience
OR
Master’s degree and 4 years of industry experience
OR
Bachelor’s degree and 6 years of industry experience
OR
Associate’s degree and 10 years of industry experience
OR
High school diploma / GED and 12 years of industry experience
Preferred Qualifications:
Doctorate degree in biostatistics and at least 4 years of post-graduate statistical experience in the pharmaceutical industry or medical research Or
Master’s 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)
Experience in Inflammation therapeutic area clinical development
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, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:
A 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
Flexible work models, including remote and hybrid work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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Application deadline
Amgen 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.
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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
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, disability status, or any other basis protected by applicable law.
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.