Biostatistical Programming Sr Mgr

Career Category

Clinical

Job 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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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 Sr Mgr

What you will do

Let’s do this. Let’s change the world. In this vital role you will work in Amgen's Biosimilar organization supporting multiple products.

• Represent the product programming function and participate in multidisciplinary project team meetings;
• Collaborate closely with Biosimilar Statisticians and other functional team members;

• Coordinate and oversee the development of dataset specifications and implementation of TLGs according to the statistical analysis plans, work practices, and project timelines in close partnership with CROs in a full-service CRO model;
• Review and approve analysis dataset specifications;
• Review or contribute to data management plans, database development, and edit checks plan;
• Contribute to and review the statistical analysis plans; and results presented in IBs, protocols, clinical study reports, integrated summaries of safety/efficacy, publications, and other documents, as required; provide support and input in protocol development, case report form design, and data collection;
• Ensure that statistical outputs, datasets, and related documentation are archived in a clear, organized, and timely fashion according to company standards;
• Proactively anticipate and communicate resource and quality issues that may impact deliverables or timelines within functional area as well as cross-functionally;

• Participate in the review of CRO Policies, SOPs and other controlled document development;
• Participate in the recruitment of programming staff within Biosimilar organization;
• Operational effectiveness, Recommendations for Program Level Consistency and Submission Readiness including data standards;
• Work with CRO and Amgen team to put together the submission data packages;
• Lead and/or contribute to the technical solutions to execute CRO programs on Amgen system and perform ad-hoc analysis to support submission and publications need;
• Lead and/or Contribute to process improvement and operational efficiency;
• Adhere to Amgen Policies, Standard operation procedures (SOPs) and other standards which are applicable to biosimilar development.

What we expect of you

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

Basic Qualifications:

• BA/BSc or higher degree in quantitative or scientific subjects
• At least 8 years of relevant statistical programming experience in a clinical development environment
• Excellent oral and written English communication skills
• Experience working effectively in a cross-functional team environment
• Advanced SAS programming skills in processing clinical data (SAS - BASE, STAT, Macro and Graph)
• Working knowledge of latest CDISC SDTM, ADaM and Define-XML standards
• Ability to lead and manage programmers in the successful and timely completion of all programming activities for a project
• Ability to effectively perform complex statistical programming and related tasks

Preferred Qualifications

• MSc or higher degree in quantitative or scientific subjects
• Familiarity with other programming languages (e.g. Java, R)
• In depth knowledge of SAS Graph, SAS STAT, SAS Macro and SQL
• Regulatory submissions experience
• Thorough understanding and experience with data quality and compliance checks, e.g., Pinnacle21
• Experience of working within a global team and CRO partners to ensure operational excellence and efficiencies.
• Prior staff development and project management experience
• Ability to train others

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.

…