Biostatistics Sr Mgr

BioSpace; Washington (District of Columbia); Hybrid; USD 150,000 - 190,000; Full time

Benefits offered by this job

Retirement plan

Bonus program

Long-term incentives

Paid time off

Flexible work model

Job summary

Amgen is seeking a Biostatistics Senior Manager in the United States to lead sophisticated statistical studies across general medicine areas. You will influence strategy, defend statistical approaches, and partner with multidisciplinary teams to ensure robust analyses for regulatory and reimbursement submissions.

The role requires advanced degrees in statistics/biostatistics and a track record of leadership in pharma/biotech statistical projects.

Qualifications

• Doctorate in Statistics/Biostatistics or related field with high statistical content and 2+ years Biostatistics experience
• Master's in Statistics/Biostatistics or related field with high statistical content and 4+ years Biostatistics experience
• Bachelor's in Statistics/Biostatistics or related field with high statistical content and 6+ years Biostatistics experience
• Associates degree and 10 years of experience or HS diploma and 12 years of experience

Responsibilities

• Inform and provide sound statistical guidance to clinical development, reimbursement, and medical affairs teams.
• Set and manage standards for strategy, study design, and statistical analysis.
• Contribute to protocols, CSRs and clinical publications; support regulatory filings.
• Lead study statisticians and supervise statistical analyses across programs.
• Anticipate resource and quality challenges to meet timelines.

Skills

Statistical guidance

Leadership

Regulatory knowledge

Collaboration

Education

Doctorate in Statistics/Biostatistics

Master's in Statistics/Biostatistics

Bachelor's in Statistics/Biostatistics

Associates or high school with experience

Job description

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Biostatistics Senior Manager

What You Will Do

Lets do this. Lets change the world. In this vital role you will achieve results through detailed goal setting, accountability measures, effective partnership, performance management, collaboration with other groups and a dedication to serving customers, both inside and outside of, CfDA (Center for Design & Analysis). The Senior Biostatistics Manager independently leads sophisticated studies and projects in the General Medicine therapeutic areas (Cardiometabolic, Inflammation, Nephrology, and Neuroscience), ensuring that the statistical aspects of clinical activities meet required standards and are robust and valid. Will also influence and supply to strategy development, defend statistical approaches and represent GBS (Global Biostatical Science) through participating in and collaborating with multidisciplinary project teams. Specific duties include:

• Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs.
• Implementing, managing and supporting standards, technical quality and consistent approaches in strategy, study design and statistical analysis.
• Planning and executing statistical contributions to protocols, Flash Memos and Clinical Study Reports (CSRs).
• Providing input for clinical publications and regulatory filing documents.
• Leading all aspects of work performed by study statisticians.
• Performing statistical and exploratory analysis of studies/projects and developing conclusions and recommendations.
• Anticipating and communicating resource and quality challenges that could impact results or timelines.
• Solid understanding of regulatory guidelines in drug development.
• Staying current in developments in the field of statistics in drug development (innovative trial design) and Amgens statistical policies, procedures and strategies.
• Contributing to process improvements and operational efficiencies.

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The Biostatistical professional we seek is an emerging leader with these qualifications.

Basic Qualifications

• Doctorate degreeinStatistics/Biostatisticsor related subject with high statistical contentand at least 2 years of Biostatistics experience OR
• Masters degreeinStatistics/Biostatisticsor related subject with high statistical contentand at least 4 years of Biostatistics experience OR
• Bachelors degreeinStatistics/Biostatisticsor related subject with high statistical contentand at least 6 years of Biostatistics experience OR
• Associates degree and 10 yearsofexperienceOR High school diploma / GED and 12 years of experience

Preferred Qualifications

• Doctorate degree in biostatics or statistics
• 5 or more years of pharma/biotech statistical experience.
• Life cycle drug development experience (pre-clinical, clinical and post-marketing).
• Experience with cardiovascular drug development.
• Proven in leadership and motivating multi-functional team to advance complex projects to completion and thoughtfully negotiate and influence
• Strong verbal and written communication combined with organizational skills and cross-cultural sensitivity
• Statistical leadership and contribution to regulatory and reimbursement submissions.
• Strong working knowledge of theoretical and applied statistics and 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, well 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.

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.

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.

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.