Amgen
Biotech company creating biologic medicines
Biostatistical Programming Senior Manager
About the job
- A BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or another related quantitative or scientific subject, with at least 8 years of statistical programming experience in a clinical development environment.
- Strong technical, communication, and leadership skills.
- Ability to lead and manage programmers to complete programming activities successfully and on time for one or multiple studies from end to end.
- Experience developing a successful offshore statistical programming team.
- Flexibility and willingness to work across different time zones.
- Advanced analysis and reporting skills in SAS, including SAS/STAT, SAS Macro, SAS Graph, and SAS SQL.
- Prior regulatory submission experience for drug approval.
- Thorough understanding of and experience with data quality and compliance checks.
- Experience in software development, including gathering user requirements, creating technical specifications, developing code, and creating and driving test plans.
- Experience working effectively in globally dispersed teams with cross-cultural partners.
- Prior staff-development leadership and project-management experience.
- Excellent oral and written English communication skills.
- Ability to perform complex statistical programming and related tasks effectively.
- Ensure successful execution and delivery of Global Statistical Programming milestone analysis deliverables and regulatory submission packages for assigned products or product groups supported by the offshore programming team.
- Work with the Global Programming Lead to implement programming strategies, functional standards, and industry requirements globally for assigned products.
- Plan and monitor project progress and address issues accordingly.
- Provide Global Statistical Programming product-level input into resource plans and budgets.
- Monitor and utilize assigned staff at the product level according to priorities.
- Lead or participate in departmental process-improvement initiatives and cross-functional working groups.
- Assist with study and system audits and inspections by internal and external bodies.
- Develop, review, and implement policies, standard operating procedures, and other controlled documents affecting Global Statistical Programming globally.
- Provide hands-on support to assigned product areas as required.
- Provide coaching and mentoring to local programming staff.
- Provide input into career-development plans for staff on assigned projects.
- An MSc or higher degree in statistics, biostatistics, mathematics, or another related quantitative or scientific subject.
- Familiarity with open-source programming tools such as R and Python, automation platforms, and emerging technologies in statistical programming.
About the company
Amgen develops medicines that treat serious illnesses by using biologic therapies made from living cells. These therapies are designed to target specific disease processes, such as cancer, cardiovascular disease, and autoimmune conditions, and are produced through biotechnology methods that create proteins or antibodies. Amgen’s products are sold to patients and healthcare providers worldwide, with revenue funding ongoing research and development to discover new treatments. The company stands out by focusing on biologic medicines at a large scale and maintaining a steady pipeline of potential therapies across multiple disease areas, supported by global manufacturing and a commitment to bringing therapies to patients. Its goal is to improve patient outcomes by discovering and delivering new, effective treatments while reinvesting a significant portion of earnings into research and development.
Company Size
10,001+
Company Stage
IPO
Headquarters
Thousand Oaks, California
Founded
1980
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Simplify's Take
What believers are saying
- Amgen raised 2026 revenue guidance to $38.2 billion-$39.4 billion after Q2 outperformance.
- Repatha sales jumped 37% to $953 million, driven by cardiologist and primary-care adoption.
- MariTide now has nine ongoing and three planned Phase 3 studies across obesity.
What critics are saying
- Prolia and XGEVA sales fell 33% in Q2 2026 as biosimilars hit.
- FDA proposed withdrawing TAVNEOS in April 2026, threatening a marketed rare-disease franchise.
- If MariTide misses 2027 endpoints, Amgen loses its next obesity growth pillar.
What makes Amgen unique
- Amgen's six growth drivers produced nearly 70% of Q2 2026 product sales.
- IMDELLTRA sales rose 115% in Q2 2026, validating Amgen's oncology engine.
- Hyderabad's 2027 Science and Innovation Center expands Amgen's seven-lab global R&D network.
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Company News
Revolution Medicines received FDA approval for daraxonrasib, the first targeted therapy for metastatic pancreatic cancer, after clinical data showed it reduced death risk by more than half. The company is clinical-stage with no current revenue and posted a $1.1 billion net loss in FY 2025. Amgen reported FY 2025 revenue of $36.7 billion, up 9.9% year-over-year, with net income of $7.7 billion and a 21% net margin. Free cash flow reached $8.1 billion. The company carries a debt-to-equity ratio of 6.3x. Revolution Medicines maintains a 0.1x debt-to-equity ratio and 9.5x current ratio but recorded negative free cash flow of $913.7 million. The company's pipeline targets RAS-driven tumours including lung cancer. A partnership with Royalty Pharma provides funding for development. Both companies face distinct risks: Amgen confronts pricing pressures and biosimilar competition, whilst Revolution Medicines carries clinical trial failure risks and competes against larger pharmaceutical firms.
Amgen reported revenue of $36.7 billion in FY 2025, up 9.9% year-over-year, with net income of $7.7 billion and a 21% net margin. The biotech giant maintains a debt-to-equity ratio of 6.3x and generated $8.1 billion in free cash flow. CRISPR Therapeutics, meanwhile, saw revenue fall 90% to $3.5 million in FY 2025, posting a net loss of $581.6 million. The gene-editing firm burns $345.9 million in cash but holds a strong current ratio of 13.3x. Its CASGEVY therapy for sickle cell disease has gained approval in the US, UK, and EU, with Vertex handling commercialisation under a 60-40 revenue split. Amgen faces pricing pressure from the Inflation Reduction Act and biosimilar competition. CRISPR Therapeutics carries clinical execution risk and ongoing intellectual property disputes.
Amgen and AstraZeneca announced positive results from the phase III DeLLphi-305 study evaluating Amgen's Imdelltra (tarlatamab) combined with AstraZeneca's Imfinzi (durvalumab) as first-line maintenance treatment for extensive-stage small-cell lung cancer (ES-SCLC). The study met its primary endpoint of overall survival and key secondary endpoint of progression-free survival, with no new safety concerns identified. ES-SCLC affects approximately 195,000 people globally. If approved, the combination would compete with Jazz Pharmaceuticals' Zepzelca plus Roche's Tecentriq, which received FDA approval in October 2025. Imdelltra, approved in 2024 for ES-SCLC progression after platinum-based chemotherapy, generated $546 million in global sales during the first half of 2026, up from $215 million in the prior-year period.
Amgen reported FY 2025 revenue of $36.7 billion, up 9.9% year-over-year, with net income of $7.7 billion and a 21% net margin. The biotech serves 17 million patients globally with treatments for heart disease, obesity, and cancer. However, three distributors—McKesson, Cencora, and Cardinal Health—accounted for 77% of gross revenues, creating concentration risk. The company's debt-to-equity ratio stood at 6.3x. Moderna posted FY 2025 revenue of $1.9 billion, down 39.2% as pandemic-related vaccine demand declined. The mRNA specialist reported a net loss of $2.8 billion, resulting in a negative 145.2% net margin due to high research and development costs. The company is pivoting its mRNA platform toward infectious diseases, cancer, and rare conditions whilst expanding through partnerships like its collaboration with Merck.
Amgen trades at $393 per share, representing a trailing multiple of 23.3 times adjusted earnings. The biotech faces declining sales from Prolia and XGEVA, down 33% year-over-year to $1.1 billion in Q2 2026, due to biosimilar competition. Six key growth medicines grew 26% year-over-year, accounting for nearly 70% of Q2 product sales. Analysts forecast the forward multiple at 17.0 times for fiscal 2026 and 16.1 times for 2027. However, consensus assumes expanding profit margins whilst Amgen increases spending. Non-GAAP research spending is set to grow in high single digits for 2026, funding nine Phase III trials for MariTide, its obesity treatment candidate. Management warned of meaningful operating expense increases in Q3 2026. The valuation depends on margin expansion materialising during this investment phase.