Associate Director - Biostatistical Programming
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 16 years of statistical programming experience in a clinical development environment.
- Strong technical, communication, and leadership skills.
- Ability to lead and manage a large team of programmers to complete programming activities for highly complex studies and regulatory submissions successfully and on time.
- 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, Macro, Graph, and SQL, or R.
- Prior regulatory submission experience for approval.
- Thorough understanding and experience with data quality and compliance checks.
- Experience working effectively in a globally dispersed team environment 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.
- Partner with Global Programming Leads and lead a large offshore team of Study Lead Programmers and Study Programmers to execute end-to-end programming activities for studies and global regulatory approval submissions for high-priority products or indications.
- Be accountable, together with the Global Programming Lead, for global statistical programming study results and submission activities for assigned products or indications.
- Lead major department-level technical or operational efficiency initiatives and ensure compliance with research and development standards; lead or serve on consultancy groups such as the Submission Consultancy Group and ADaM Consultancy Group.
- Drive piloting and integration of artificial intelligence, statistical programming automation tools, and open-source platforms to improve quality and efficiency.
- Ensure successful execution and delivery of statistical programming milestone analysis deliverables and regulatory submission packages for assigned products.
- Work with the Global Programming Lead to implement programming strategies, including functional standards and industry requirements, for assigned products globally.
- Plan and monitor project progress and address issues.
- Provide product-level input into developing and managing statistical programming resource plans and budgets.
- Monitor and utilize assigned staff at product level according to priorities.
- Lead or participate in departmental process-improvement initiatives and cross-functional working groups.
- Represent Global Statistical Programming in 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.
- Coach and mentor Global Statistical Programming staff globally.
- Provide input into career-development plans for direct reports and 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
- Q2 2026 revenue rose 10% to $10.1 billion, and guidance increased to $39.4 billion.
- Imdelltra sales jumped 219% year over year in Q1 2026, signaling rapid launch traction.
- Repatha sales rose 37% in Q2 2026, driven by expanding cardiology and primary-care adoption.
What critics are saying
- Prolia and Enbrel face accelerating biosimilar erosion; Amgen expects continued sales declines through 2026.
- Three distributors generated 77% of gross revenue in 2026, concentrating pricing leverage brutally.
- MariTide failure would crater obesity optionality and expose Amgen's growth to aging franchises.
What makes Amgen unique
- September 2026 Imdelltra-IMFINZI phase III hit overall survival in first-line ES-SCLC.
- August 2026 Repatha reduced death risk in high-risk patients, strengthening Amgen's cardiovascular moat.
- MariTide's monthly-or-less dosing and nine Phase III studies separate it from weekly GLP-1s.
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Company News
Amgen raised its quarterly dividend 6% to $2.52 per share, marking its 14th consecutive annual increase since starting payouts in 2011. The biotech now pays $10.08 annually, yielding 2.36% at current share prices of $418.13. The dividend appears well covered. Amgen generated $8.1 billion in free cash flow in 2025 against $5.1 billion in dividend payments. Second quarter 2026 free cash flow reached $3.5 billion whilst dividends consumed $1.4 billion. However, biosimilar competition is eroding legacy revenue. Prolia and XGEVA sales dropped 33% whilst Enbrel fell 37%. The company carries $57 billion in debt. Future dividend growth may hinge on Phase 3 results for MariTide, Amgen's obesity candidate. The company follows a steady raise pattern similar to Johnson & Johnson, contrasting with Pfizer's post-COVID payout struggles.
Vertex Pharmaceuticals reported strong second-quarter results, with revenue rising 12% year-over-year to $3.33 billion and earnings per share climbing 8% to $4.31. The company posted positive Phase 2b results for inaxaplin, an experimental treatment for APOL1-mediated kidney disease, showing it reduced proteinuria in patients with modest protein levels and those with type 2 diabetes. Vertex expects approval for povetacicept, a treatment for IgA nephropathy, by November. The company continues diversifying beyond its core cystic fibrosis franchise, which provides predictable revenue as patients require lifelong treatment. Meanwhile, Amgen has also outperformed the broader market this year, though specific recent developments were not detailed in the source material.
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.