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Biostatistical Programming Manager

Biostatistical Programming Manager

AmgenNewbury Park, CA, US
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Biostatistical Programming Manager.Join Amgens Mission of Serving Patients.At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Biostatistical Programming Manager

Biostatistical Programming Manager

AmgenNewbury Park, CA, US
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Biostatistical Programming Manager

Join Amgens Mission of Serving Patients

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. 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.

What You Will Do

Lets do this. Lets change the world. In this vital role you will ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically accurate.

This 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. This 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 dynamic professional we seek is a manager with these qualifications.

Basic Qualifications :

  • Doctorate degree OR
  • Masters degree and 2 years of statistical programming experience OR
  • Bachelors degree and 4 years of statistical programming experience OR
  • Associates degree and 8 years of statistical programming experience OR
  • High school diploma / GED and 10 years of statistical programming experience

    • Preferred Qualifications :

  • Masters 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, 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, including remote and hybrid work arrangements, where possible

    • Apply now and make a lasting impact with the Amgen team.

    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.

    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.