Biostatistical Programming Senior Manager

March 29

Apply Now

Receive Emails with Similar Jobs

Amgen

WebsiteLinkedInAll Job Openings

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

Biologics • Human therapeutics • Development of novel products

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 Post-IPO Debt on 2022-12

📋 Description

• Ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically accurate. • Lead a group of Oncology and other therapeutic area products. • Accountable and responsible for Global Statistical Programming study results and submission activities for the assigned product areas. • Set and drive forward the programming strategies such as functional standards and industry requirements for the assigned product areas globally. • Plan and monitor progress of projects and address issues accordingly. • Support GSP Functional Service Provider (FSP) relationship and oversight; Ensure the product goals can be met via the FSP staff. • Provide GSP product level input to developing and managing resource plans and budgets for GSP. • Efficiently and effectively monitor and utilize assigned staff at product level according to priorities. • Lead and/or participate in departmental process improvement initiatives and cross-functional working groups. • Assist in study and system audits and inspections by internal and external bodies. • Develop, review, and implement Policies, SOPs and other controlled documents affecting GSP globally. • Provide hands-on support to the assigned product areas as required. • Provide coaching and mentoring to staff. • Provide input into career development plans for all staff on assigned projects.

🎯 Requirements

• Doctorate degree and 2 years of statistical programming in Pharmaceutical industry experience OR • Master’s degree and 6 years of statistical programming in Pharmaceutical industry experience OR • Bachelor’s degree and 8 years of statistical programming in Pharmaceutical industry experience OR • Associate’s degree and 10 years of statistical programming in Pharmaceutical industry experience OR • High school diploma / GED and 12 years of statistical programming in Pharmaceutical industry experience • In depth knowledge of SAS Graph, SAS STAT, SAS Macro and SQL • Advanced SAS analysis and reporting skills • Prior regulatory submission experience • Thorough understanding and experience with data quality and compliance checks • Experience in software development (e.g., gathering user requirements, creating technical specifications, developing code, creating, and driving test plans). • Familiar with R Programming language • Statistical programming experience in a clinical development environment • Experience working effectively in a globally dispersed team environment with cross-cultural partners • Ability to lead and manage programmers in the successful and timely completion of all programming activities for a study or multiple studies from end to end • Prior staff development leadership and project management experience • Excellent oral and written communication skills • Ability to effectively perform complex statistical programming and related tasks

🏖️ Benefits

• 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 and bi-annual company-wide shutdowns • Flexible work models, including remote work arrangements, where possible