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.
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.
careers.amgen.com
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.
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 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.
We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.
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- Salary Range
- 151,838.05USD -205,427.95 USD
