Biostatistics Sr. Manager

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together - researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Biostatistics Sr. Manager

What you will do

Let’s do this. Let’s change the world.

As a Biostatistics Sr. Manager, you will lead study-level statistical deliverables with substantial independence. This role manages small teams, mentors staff and ensures the delivery of high-quality statistical outputs that meet CfDA and regulatory expectations.

Responsibilities:

• Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs.
• Plan and execute statistical contributions to protocols, Flash Memos and Clinical Study Reports (CSRs)
• Implement, manage and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis.
• Knowledgeable of developments in the field of statistics in drug development (innovative trial design) and Amgen’s statistical policies, procedures and strategies.
• Understand, promote, and communicate innovative and standard statistical methodologies, trial design, data analysis, and medical / clinical understanding for product
• Oversee statistical contributions to key design elements, protocols, randomization specifications, statistical analysis plans, tables, figures and listing shells, submission data file specifications, and other key study-related documentation
• Collaborate cross-functionally to deliver robust, valid and scientifically rigorous analysis results in Table, Figure and Listings (TFLs), Flash Memos (FM), Clinical Study Reports (CSRs), clinical publications, and other communications
• Serve as the GBS lead on the Clinical Study Team leadership team to execute clinical trials according to the protocol, performing risk assessments and ensuring quality data collection and alignment between data collection and study objectives
• Contribute to clinical publications, regulatory filing documents, reimbursement documents and other communications for product or study
• Provide statistical consultancy, training, and advice within Amgen
• Contributing to process improvement initiatives and operational efficiencies.
• Oversee FSP statisticians and check their contributions for quality
• Ensure statistics sections of the TMF are maintained and up-to-date
• Opportunity to manage staff, e.g. external contractors
• Opportunity to serve as a product regional lead

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a strategic Biostatistics leader with a passion for tech-enabled transformation.

Basic Qualifications:

• Doctorate degree in Statistics/Biostatistics or related subject with high statistical content and
• At least 2 years of post-graduate statistical experience in the pharmaceutical industry or medical research

Or

• Master’s degree in Statistics/Biostatistics or related subject with high statistical content and
• At least 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research

Or

• Bachelor’s degree in Statistics/Biostatistics or related subject with high statistical content and
• At least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research

Preferred Skills:

• 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)
• 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

and make a lasting impact with the Amgen team.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.

Sponsorship

Sponsorship for this role is not guaranteed.

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.