Process Development Senior Scientist

Amgen • Cambridge, MA

22h • Remote

About The Position

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. Process Development Senior Scientist What you will do and what we expect of you Let’s do this. Let’s change the world. In this vital role you will:

Requirements

• 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;
• and 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.

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.
• May telecommute.

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, 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, including remote and hybrid work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level