Full-Time
Senior Manager Safety Biostatistics
Updated on 9/5/2026
Amgen
10,001+ employees
Biotech company creating biologic medicines
No salary listed
Hyderabad, Telangana, India
In Person
Master's, PhD
 Biology & Biotech (1) |
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- An MSc or PhD in Statistics or Biostatistics and 12 or more years of relevant experience.
- Ability to apply statistical methods in clinical development.
- Proficiency in an analytical application such as R or SAS.
- Represent the Biostatistics function in multidisciplinary project team meetings and collaborate with cross-functional partners to provide statistical guidance for safety assessment.
- Act as an independent statistician by assessing and interpreting aggregate safety data across multiple studies and products and formulating conclusions and recommendations.
- Provide safety statistics expertise for aggregated safety analysis plans and safety assessment and reporting activities across multiple studies and products.
- Develop, maintain, and set standards for controlled process documents, including best practices for aggregate safety statistical methodologies.
- Support the development and application of training and guidance materials across programs.
- Support innovative safety-assessment projects involving data visualizations, decision-making toolkits, advanced analytics, and artificial intelligence integration.
- Maintain familiarity with statistical policies, strategies, and regulatory guidance, and stay current with statistical methods relevant to safety assessment and reporting.
- Strong technical expertise with hands-on experience in statistical design and analysis.
- Clinical trial experience within a pharmaceutical or medical research environment.
- Experience analyzing safety data using Bayesian or other advanced statistical methodologies in a clinical trial setting.
- Experience developing or supervising the development of data visualization tools and analytical applications such as R/Shiny.
- Interest in and ability to stay current with analytical innovation relevant to safety assessment, including advanced analytics and artificial-intelligence-enabled approaches.
- Ability to work effectively in a globally dispersed, cross-cultural team environment.
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%, and management raised full-year guidance again.
- Repatha sales jumped 37% in Q2 2026 on stronger cardiology and primary-care demand.
- Amgen approved IMDYLLTRA in Europe and opened a 2027 Hyderabad innovation center.
What critics are saying
- FDA scrutiny threatens Tavneos withdrawal after the NEJM retraction and data-alteration probe.
- Prolia sales fell 32% in Q2 2026 as biosimilar competition intensifies.
- MariTide failure would leave Amgen dependent on aging brands and biosimilars after 2027.
What makes Amgen unique
- Amgen sells multiple billion-dollar medicines, reducing dependence on any single franchise.
- Repatha now shows hard cardiovascular mortality benefit, strengthening payer and physician adoption.
- MariTide's monthly dosing targets a convenience gap versus weekly GLP-1 incumbents.
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Company News
Jim Cramer highlighted Amgen's cholesterol drug Repatha as a key driver behind the company's 31% year-to-date rally, calling it an overlooked catalyst by Wall Street. The injectable treatment, administered every two weeks, reduces death risk by 20% in patients at high risk for heart attack or stroke. Repatha generated $953 million in second-quarter sales, up 37% year-over-year. US new prescriptions surged over 50%, split evenly between cardiologist use and primary-care adoption for high-risk patients. Cramer noted the drug works against diabetes and high cholesterol, though insurance reimbursement has posed challenges. Amgen trades at a forward PE of 19, compared to Eli Lilly's 32, whilst outperforming Lilly's 10% gain this year. Repatha is one of six growth drivers representing nearly 70% of Amgen's product sales. The company raised full-year revenue guidance to $38.2-$39.4 billion.
Amgen shares jumped 3.5% to $440.08 on Wednesday as healthcare stocks reached record highs. The biotech company reported second-quarter revenue of $10.1 billion, up 10%, whilst GAAP earnings surged 65% to $4.37 per share. Twenty-two of Amgen's medicines posted double-digit sales growth, with seventeen products generating over $1 billion in annualised sales. Six key growth products climbed 26% and now account for nearly 70% of product revenue. The rally came as investors rotated into healthcare following excitement around Merck and Moderna's melanoma breakthrough. However, Amgen now trades at a 19% premium to its fair value estimate of $365.04, putting pressure on execution as some products like Prolia face headwinds.
Amgen and Regeneron could benefit from surging demand for GLP-1 drugs, which traditionally treated diabetes but now address obesity and obstructive sleep apnea. Amgen's stock is up 27% this year, with second-quarter revenue rising 10% year-over-year to $10.1 billion. The company is testing MariTide, an investigational GLP-1 medicine, in phase 3 studies for weight management and diabetes. MariTide could be administered monthly or less frequently, offering a convenience advantage over current daily or weekly treatments. Regeneron is also positioned to capitalise on the GLP-1 market expansion. Both companies present alternatives to current market leaders Eli Lilly and Novo Nordisk for investors seeking exposure to the growing GLP-1 drug category.
Amgen announced plans to open a new Science and Innovation Center in Genome Valley, Hyderabad, expected to be operational in 2027. The facility will join Amgen's global Research and Development network of seven research laboratories, expanding the company's scientific capabilities. The center will bring together scientists and technologists across discovery chemistry, drug metabolism and pharmacokinetics, and precision medicine. It will integrate experimental science with data and digital innovation to accelerate the discovery and development of medicines. "The new center in Genome Valley expands the way we integrate experimental science with data and technology across our global research capabilities," said Jay Bradner, executive vice president of Research and Development, Artificial Intelligence and Data at Amgen. The facility will complement Amgen's existing technology and innovation site in Hyderabad.
Amgen's modeled fair value has risen from $352.23 to $371.93 per share following strong Q2 results and updated analyst targets. Several firms, including Scotiabank, TD Cowen, BMO Capital, and Oppenheimer, lifted price targets to around $450, citing earnings revisions and a diversified product portfolio. Bernstein noted a 6.8% revenue beat and 12.5% non-GAAP EPS beat in Q2, with raised full-year guidance driven by portfolio-wide execution. Strength came from products including Repatha, Tezspire, Uplizna, Evenity, and Imdelltra. However, Wells Fargo and Citi maintain cautious stances with Equal Weight and Neutral ratings, suggesting current performance may already be priced in. BofA kept its Underperform rating, describing 2026 as focused on execution ahead of key 2027 readouts.