Biostatistical Programming Sr Mg
The Statistical Programming Senior Manager 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.
- 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
- 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
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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, or disability status.