Amgen
Biostatistical Programming Senior Manager- US Remote
Amgen, Washington, District of Columbia, us, 20022
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.
Biostatistical Programming Senior Manager
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically accurate. The Biostatistical Programming Senior Manager (Product Lead Programmer) lead a group of Oncology and other therapeutic area products. This Senior Manager will be accountable and responsible for Global Statistical Programming study results and submission activities for the assigned product areas.
Accountable and responsible for Global Statistical Programming (GSP) study deliverables and submission activities for a group of Amgen products.
Set and drive forward the programming strategies such as functional standards and industry requirements for the assigned product areas globally.
Plan and monitor progress of projects and address issues accordingly.
Support GSP Functional Service Provider (FSP) relationship and oversight; Ensure the product goals can be met via the FSP staff.
Provide GSP product level input to developing and managing resource plans and budgets for GSP.
Efficiently and effectively monitor and utilize assigned staff at product level according to priorities.
Lead and/or participate in departmental process improvement initiatives and cross-functional working groups.
Assist in study and system audits and inspections by internal and external bodies.
Develop, review, and implement Policies, SOPs and other controlled documents affecting GSP globally.
Provide hands-on support to the assigned product areas as required.
Provide coaching and mentoring to staff.
Provide input into career development plans for all staff on assigned projects.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Biostatistical Programming Senior Manager we seek is a leader with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of statistical programming in Pharmaceutical industry experience OR Master’s degree and 6 years of statistical programming in Pharmaceutical industry experience OR Bachelor’s degree and 8 years of statistical programming in Pharmaceutical industry experience OR Associate’s degree and 10 years of statistical programming in Pharmaceutical industry experience OR High school diploma / GED and 12 years of statistical programming in Pharmaceutical industry experience
Preferred Qualifications:
In depth knowledge of SAS Graph, SAS STAT, SAS Macro and SQL
Advanced SAS analysis and reporting skills
Prior regulatory submission experience
Thorough understanding and experience with data quality and compliance checks
Experience in software development (e.g., gathering user requirements, creating technical specifications, developing code, creating, and driving test plans).
Familiar with R Programming language
Statistical programming experience in a clinical development environment
Experience working effectively in a globally dispersed team environment with cross-cultural partners
Ability to lead and manage programmers in the successful and timely completion of all programming activities for a study or multiple studies from end to end
Prior staff development leadership and project management experience
Excellent oral and written communication skills
Ability to effectively perform complex statistical programming and related tasks
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising 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 including:
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 and bi-annual company-wide shutdowns
Flexible work models, including remote 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
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
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 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.
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.
Biostatistical Programming Senior Manager
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically accurate. The Biostatistical Programming Senior Manager (Product Lead Programmer) lead a group of Oncology and other therapeutic area products. This Senior Manager will be accountable and responsible for Global Statistical Programming study results and submission activities for the assigned product areas.
Accountable and responsible for Global Statistical Programming (GSP) study deliverables and submission activities for a group of Amgen products.
Set and drive forward the programming strategies such as functional standards and industry requirements for the assigned product areas globally.
Plan and monitor progress of projects and address issues accordingly.
Support GSP Functional Service Provider (FSP) relationship and oversight; Ensure the product goals can be met via the FSP staff.
Provide GSP product level input to developing and managing resource plans and budgets for GSP.
Efficiently and effectively monitor and utilize assigned staff at product level according to priorities.
Lead and/or participate in departmental process improvement initiatives and cross-functional working groups.
Assist in study and system audits and inspections by internal and external bodies.
Develop, review, and implement Policies, SOPs and other controlled documents affecting GSP globally.
Provide hands-on support to the assigned product areas as required.
Provide coaching and mentoring to staff.
Provide input into career development plans for all staff on assigned projects.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Biostatistical Programming Senior Manager we seek is a leader with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of statistical programming in Pharmaceutical industry experience OR Master’s degree and 6 years of statistical programming in Pharmaceutical industry experience OR Bachelor’s degree and 8 years of statistical programming in Pharmaceutical industry experience OR Associate’s degree and 10 years of statistical programming in Pharmaceutical industry experience OR High school diploma / GED and 12 years of statistical programming in Pharmaceutical industry experience
Preferred Qualifications:
In depth knowledge of SAS Graph, SAS STAT, SAS Macro and SQL
Advanced SAS analysis and reporting skills
Prior regulatory submission experience
Thorough understanding and experience with data quality and compliance checks
Experience in software development (e.g., gathering user requirements, creating technical specifications, developing code, creating, and driving test plans).
Familiar with R Programming language
Statistical programming experience in a clinical development environment
Experience working effectively in a globally dispersed team environment with cross-cultural partners
Ability to lead and manage programmers in the successful and timely completion of all programming activities for a study or multiple studies from end to end
Prior staff development leadership and project management experience
Excellent oral and written communication skills
Ability to effectively perform complex statistical programming and related tasks
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising 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 including:
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 and bi-annual company-wide shutdowns
Flexible work models, including remote 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
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
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 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.