Director Biostatistical Programming

Career Category

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. 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.

Director Biostatistical Programming

What you will do

Let’s do this. Let’s change the world. In this vital role you will The Director will build an observational research programming team in India to support global generation of real-world evidence. The Director will report to an Executive Director of Biostatistical Programming within CfOR’s global organization.

The Director provides leadership to the local 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 local programming team and planning, organizing, and managing resources to ensure high quality and timely delivery of observational research programming deliverables. The Director 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. The Director will also be responsible for team oversight, monitoring team performance, developing individual staff, building a cohesive team and integrating the team and processes into global organizational structures and processes.

·Recruit, 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

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)
• Manage staff performance and oversee staff assignments and utilization.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Doctorate degree and 4 years of relevant statistical programming/systems engineering/application programming experience in a clinical development or life sciences setting OR
• Master’s degree and 8 years of relevant statistical programming/systems engineering/application programming experience in a clinical development or life sciences setting OR
• Bachelor’s degree and 10 years of relevant statistical programming/systems engineering/application programming experience in a clinical development or life sciences setting

And

• 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• Bachelor’s or Master’s degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject
• Ten (10) years clinical research and development programming 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
• Team participation and effectiveness
• 10+ years of relevant statistical programming or Software Development experience in a clinical development environment supporting statistical programming
• Clinical programming technologies knowledge for data collection, curation, and analysis (SAS, SQL, R, Python)
• Experienced leader with systems architecture, platform technologies including ASP, Cloud, and other technologies
• Experience working effectively in a globally dispersed team environment with cross-cultural partners
• Excellent oral and written English communication skills
• Strong negotiation skills
• Prior staff development leadership and project management experience
• In-Depth experience in project management to enable deliverables done on time and to a high quality
• Working experience with real-world patient healthcare data
• Working experience in submissions, ad-hoc tasks, and complex data mappings
• Experience of data sciences, automation, and artificial intelligence in support of stat programming activities
• Thorough understanding of therapeutic area (e.g. oncology, general medicine, etc) standards
• 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.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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.