Biostatistics Sr Manager

Career Category ClinicalJob DescriptionJoin Amgen’s Mission of Serving PatientsAt 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 ManagerWhat you will doLet’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.Accountabilities

• Provide dedicated support for Exploratory Biostatistics

• Execute key projects, deliverables and operational tasks related to exploratory biostatistical strategy, technical expertise, and reporting within designated studies / products

• Execute statistics strategy, implement standards and approaches to ensure quality and technical excellence in strategy, exploratory analysis planning, and statistical analyses

• Advise and manage statisticians on best practices and techniques for exploratory analysis to align with industry standards and to provide valid, robust conclusions

• Opportunity to serve as the product or disease area exploratory analysis lead, as needed

ResponsibilitiesStatistical Excellence

• Utilize knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, clinical trial biomarker (CTA) and companion diagnostics (CDx) co-development, and precision Medicine organization.

• Plan and execute statistical activities contributing to exploratory statistical analysis plans, reports and publications

• 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 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 EBG lead on the Evidence Generation Team (EGT) or Clinical Study Team (CST) with exploratory analysis needs to support Precision Medicine or drug/CDx codevelopment

• Contribute to clinical publications, regulatory filing documents, reimbursement documents and other communications for product or study

• Provide statistical consultancy, training, and advice within Amgen

• Contribute to process improvement initiatives and operational efficiencies

• Oversee FSP statisticians and check their contributions for quality

• Opportunity to manage staff, e.g.external contractors

• Opportunity to serve as a product or disease area exploratory analysis biostatistical lead to support Precision Medicine

What we expect of youWe 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 in biostatistics, mathematics, physics, and related quantitative fieldsORMaster’s degree and 4 years of industry experience in biostatistics, mathematics, physics, and related quantitative fieldsORBachelor’s degree and 6 years of industry experience in biostatistics, mathematics, physics, and related quantitative fieldsORAssociate’s degree and 10 years of industry experience in biostatistics, mathematics, physics, and related quantitative fieldsORHigh school diploma / GED and 12 years of industry experience in biostatistics, mathematics, physics, and related quantitative fieldsPreferred Qualifications:

• Doctorate degree in biostatistics, mathematics, physics, and related quantitative fields and at least 4 years of post-graduate statistical or data science experience Or
• Master’s degree in biostatistics and at least 8 years of post-graduate statistical and data analysis 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 usAs 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 nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comIn 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 deadlineAmgen 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..Salary Range 153,319.00 USD - 181,444.00 USD
Apply for the job now! Apply for this job