Biostatistical Programming Manager
US - California - Thousand Oaks - Field/Remote
Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.Career Category
ClinicalJob Description
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.
Biostatistical Programming Manager
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 Technical Manager will ensure that projects outsourced to our Functional Service Providers (FSPs) are aligned with our priorities and meet Amgen timeline, quality, data standards and compliance expectations. The Technical Manager will also provide technical consultancy to our FSPs on Amgen processes, tools and utilities.
Responsibilities
Oversee the execution and quality of projects managed by our FSPs per Amgen Global Statistical Programming (GSP) Quality Oversight Plan (QOP)
Align FSP assignments with Amgen Development priorities
Ensure that FSP programming meets quality, compliance, timeline, and productivity expectations
Contribute to FSP training material development and revisions, and conducting the initial training to FSP staff
Provide guidance and technical consultancy to FSP Study Lead Programmers (SLP) on Amgen processes, tools, and utilities
Contribute to FSP performance metrics development, data collection, and reporting
Review project documentations such as specifications, issue logs, deliverable status for accuracy and completeness
Advise FSP SLP on study-specific questions for specifications, documentation, and coding
Lead/contribute to GSP continuous improvement initiatives
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is proficient with these qualifications.
Basic Qualifications:
Doctorate degree OR
Master’s degree and 2 years of statistical programming experience OR
Bachelor’s degree and 4 years of statistical programming experience OR
Associate’s degree and 8 years of statistical programming experience OR
High school diploma / GED and 10 years of statistical programming experience
Preferred Qualifications:
MSc in Computer Science, Statistics, Mathematics, Life Sciences or another relevant scientific subject
Regulatory submission experience
Vendor and resource management experience
Familiarity with other programming languages such as R or Python
In-depth knowledge of SAS/Graph and Stat packages
Thorough understanding of data compliance checks such as Pinnacle 21
6+ years of statistical programming in biopharmaceutical industry
Thorough understanding of clinical trial processes from data collection to analysis reporting
Ability to lead programmers in successful completion of all study programming activities and provide guidance on technical and process questions
Experience working in a globally dispersed team on Phase 1-4 clinical trials
Excellent oral and written English communication skills; strong negotiation skills
Advanced SAS analysis and reporting skills including SAS Base, macro, and SQL
Hands-on experience in specifying and implementing SDTM and ADaM data sets and TFLs
What you can expect from 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
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.
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. 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.
.Salary Range
132,792.00 USD - 150,270.00 USDTags: Computer Science Mathematics Python R Research SAS SQL Statistics
Perks/benefits: Career development Competitive pay Equity / stock options Flex hours Flex vacation Health care Insurance Salary bonus Startup environment
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