Amgen · 2 hours ago
Process Development Senior Scientist
Cambridge, MA
Full-time
Hybrid
Mid, Senior Level
$140K/yr - $171K/yr
1+ years expAmgen is a leading biotechnology company dedicated to serving patients with serious illnesses. The Process Development Senior Scientist will design and analyze clinical trials, provide statistical contributions, and communicate the role of the Global Biostatistics department while contributing to the field of drug development.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Design and analyze clinical trials, using statistical methods to support drug development and regulatory submissions
Provide statistical contributions, statistical review, and quality control of Key Design Elements, protocols, randomization specifications, Statistical Analysis Plans, Table, Listing and Graph shells, Submission Data File specifications, other key study related documentation, protocol deviations, Flash Memos, Clinical Study Reports, clinical publications, and other communications; Completing statistical analysis of individual studies/projects
Publish applied research in scientific journals and books, and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings (biopharmaceutical industry and academic meetings)
Being familiar with statistical policy and strategies
Stay abreast of the latest developments in the field of statistics in drug development and contribute to scientific advances in the field
Communicate the role of the Global Biostatistics department, and contribute to statistical training within Global Biostatistics
Assist in the review of Amgen Policies, SOPs, and other controlled documents
Assist with study and systems audits conducted by Amgen internally and external bodies
Use SAS and R to produce comprehensive tables and graphs to collect any summarize outcomes
Qualification
Required
Master's degree or foreign equivalent in Statistics, Biostatistics or related field
Completion of a university-level course, research project, internship, thesis, or one year of experience in the job offered or experience in any occupation in which the required experience was gained
Designing experiments or clinical trials to meet project requirements, regulatory standards, or scientific objectives, including development of protocols and Statistical Analysis Plans (SAPs)
Utilizing SAS, R or other statistical software to analyze clinical study data or observational study data
Assessing, implementing or developing new statistical methods to improve efficiency and validity of clinical trials
Utilizing R or other statistical software to perform simulations to evaluate operating characteristics of analytic methods or design options
Utilizing programming software to develop tools to evaluate methods or statistical designs including creation of software packages or interactive tools
Performing causal inference analyses on clinical trial or observational datasets to address potential biases and confounding factors
Employ trial design strategies to mitigate challenges such as high dropout, skewed distributions, missing data, and confounding, including the use of robust regression and imputation
Benefits
Stock
Retirement
Medical
Life and disability insurance
Eligibility for an annual bonus or for sales roles, other incentive compensation
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
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, including remote and hybrid work arrangements, where possible
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
Recent News
2026-01-24
2026-01-22
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