Senior Biostatistical Programming Manager

🔥 26 minutes ago

🇺🇸 United States – Remote

💵 $151.8k - $205.4k / year

⏰ Full Time

🟠 Senior

👔 Manager

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $28.5G Post-IPO Debt on 2022-12

Biotechnology • Pharmaceuticals • Science

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.

📋 Description

• In this vital role you will be responsible for programming activities supporting the obesity therapeutic area. • This individual will report to the Director of General Medicine - Obesity programming in CfOR’s Data & Analytic Center. • The senior manager provides leadership to the obesity programming team in the development and execution of real-world evidence (RWE) observational studies and ensures adequate and timely delivery of results. • The individual is responsible for oversight of the US programming team and planning, organizing, and managing resources to ensure high quality and timely delivery of observational research programming deliverables. • The senior manager leads and contributes to efforts to identify, develop and implement departmental standards, applications, processes , and training. • Key activities include: Lead, manage , and develop programming staff, Provide technical solutions to programming problems within CfOR, Lead and develop technical programming and process improvement initiatives within CfOR, Represent the programming function and participate in multidisciplinary project team meetings, Project manage all programming activities, according to agreed resource and timeline plans, Ensure all programming activities on the project adhere to departmental standards, Write and/or review and approve all programming plans, Write and/or review and approve analysis dataset specifications, Review and approve key study-related documents produced by other functions, e.g. SAPs , CRF, Data Management Plan, etc. • Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications. • Write, test, validate and execute department-, product- and protocol-level macros and utilities • Oversee the work of outsourced resources assigned to project, Review Requests for Proposals (RFPs) from outsourcing vendors for programming services, Lead and/or participate in the development and review of CfOR Policies, SOPs and other controlled documents, Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings, Participate in the recruitment of programming staff, Actively participate in external professional organizations, conferences and/or meetings, Provide input to and participate in intra-departmental and CfOR meetings, Contribute to the continuous improvement of programming, CfOR, and Research and Development ( R&D )

🎯 Requirements

• Doctorate degree and 2 years of experience OR Master’s degree and 4 years of experience OR Bachelor’s degree and 6 years of experience OR Associate’s degree and 10 years of experience OR High school diploma / GED and 12 years of experience • Preferred Qualifications Bachelor ’ s or Master ’ s degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject • For therapeutic area support, ten (10) years clinical research and development programming and managing experience • For system and process support, ten (10) years project management, software application development and managing experience • Drug Development (pre-, early, late and/or observational) in related industries or academic research) • Project planning and management • Process improvement leadership • Participation in the development of policies and SOPs • International co-operation • Computer programming, preferably SAS or other procedural languages • Understanding of computer operating systems, UNIX preferred • Biostatistical Programming within Drug Development • Drug Development Process & Operations • Software development & design

🏖️ Benefits

• 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 where possible.