Biostatistical Programming Manager

🕒 June 23

🇺🇸 United States – Remote

💵 $130k - $140k / year

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 55%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

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

• Provide rapid response statistical programming support for urgent internal and external requests • Serve as a lead programmer for studies and projects, including Data Access Plan activities, unblinding efforts, and special projects • Deliver hands-on programming support for SDTM, ADaM, Tables, Listings, and Figures, and other study and regulatory submission deliverables • Oversee execution and quality of projects managed by FSP partners according to Amgen’s Global Statistical Programming Quality Oversight Plan • Ensure FSP and in-house programming deliverables meet quality, compliance, timeline, and productivity expectations • Mitigate at-risk projects through technical expertise, programming support, and operational guidance • Contribute to training material development and delivery for internal teams and FSP partners • Provide guidance and technical consultancy on Amgen processes, tools, and utilities • Lead or contribute to continuous improvement and cross-functional initiatives, including inspection readiness, process improvement, innovation, and training • Contribute to performance metrics development, data collection, and reporting • Review project documentation, including specifications, issue logs, and deliverable status, for accuracy and completeness • Primarily support programs within the Obesity Therapeutic Area and collaborate closely with cross-functional teams

🎯 Requirements

• Doctorate degree OR Master’s degree and 2 years of statistical programming experience OR Bachelor’s degree and 4 years of statistical programming experience OR Associate’s degree and 8 years of statistical programming experience OR High school diploma / GED and 10 years of statistical programming experience • 6+ years of statistical programming in biopharmaceutical industry • Regulatory submission experience • Strong hands-on SAS programming expertise including SAS Base, Macro, SQL, SAS/Graph and Stat packages • Experience with R programming for clinical trial analyses, data manipulation, reporting and visualization preferred • Familiarity with additional programming languages and tools such as Python preferred • Hands-on experience developing and validating SDTM, ADaM datasets, and TFLs • Thorough understanding of clinical trial processes from data collection through analysis and reporting • Ability to lead programmers in successful completion of all study programming activities and provide guidance on technical and process questions • Strong understanding of data standards and compliance checks including Pinnacle 21 • Experience providing quality oversight for outsourced and internal programming deliverables • Ability to troubleshoot complex technical issues and turnaround at-risk projects • Experience working in a globally dispersed team on Phase 1-4 clinical trials • Experience supporting clinical development programs within the Obesity Therapeutic Area preferred • Understanding of obesity clinical endpoints, data standards, and regulatory considerations highly desirable • Excellent oral and written English communication skills; strong collaboration, negotiation, and organizational skills

🏖️ 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 • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Work/life balance