Biostatistical Programming Senior Manager

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. 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, 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 Senior Manager

What you will do

Let's do this. Let's change the world. In this vital role you will be responsible for programming activities supporting the obesity therapeutic area.? This individual will report to the Director of General Medicine - Obesity programming in CfOR's Data & Analytic Center.

The senior manager provides leadership to the obesity programming team in the development and execution of real-world evidence (RWE) observational studies and ensures adequate and timely delivery of results. The individual is responsible for oversight of the US programming team and planning, organizing, and managing resources to ensure high quality and timely delivery of observational research programming deliverables. The senior manager leads and contributes to efforts to identify, develop and implement departmental standards, applications, processes, and training. This position requires management of a technical team and a comprehensive understanding of statistical programming languages and platforms, real world data, claims, and EMR databases.

Key activities include:

• Lead, manage, and develop programming staff

• Provide technical solutions to programming problems within CfOR

• Lead and develop technical programming and process improvement initiatives within CfOR

• Represent the programming function and participate in multidisciplinary project team meetings

• Project manage all programming activities, according to agreed resource and timeline plans

• Ensure all programming activities on the project adhere to departmental standards

• Write and/or review and approve all programming plans

• Write and/or review and approve analysis dataset specifications

• Review and approve key study-related documents produced by other functions, e.g.SAPs, CRF, Data Management Plan, etc.

• Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications

• Write, test, validate and execute department-, product- and protocol-level macros and utilities

• Oversee the work of outsourced resources assigned to project

• Review Requests for Proposals (RFPs) from outsourcing vendors for programming services

• Lead and/or participate in the development and review of CfOR Policies, SOPs and other controlled documents

• Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings

• Participate in the recruitment of programming staff

• Actively participate in external professional organizations, conferences and/or meetings

• Provide input to and participate in intra-departmental and CfOR meetings

• Contribute to the continuous improvement of programming, CfOR, and Research and Development (R&D)

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Biostatistical Programming Senior Managerwe seek is a proffesional with these qualifications.

• Doctorate degree and 2 years of experienceORMaster's degree and 4 years of experienceORBachelor's degree and 6 years ofexperienceORAssociate's degree and 10 years ofexperienceORHigh school diploma / GED and 12 years of experience

Preferred Qualifications

• Bachelor's or Master's degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject

• For therapeutic area support, ten (10) years clinical research and development programming and managing experience

• For system and process support, ten (10) years project management, software application development and managing experience

• Drug Development (pre-, early, late and/or observational) in related industries or academic research)

• Project planning and management

• Process improvement leadership

• Participation in the development of policies and SOPs

• International co-operation

• Computer programming, preferably SAS or other procedural languages

• Understanding of computer operating systems, UNIX preferred

• Biostatistical Programming within Drug Development

• Drug Development Process & Operations

• Software development & design

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, 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

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

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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.

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.