Full-Time
Biostatistical Programming Senior Associate
Updated on 9/10/2026
Amgen
10,001+ employees
Biotech company creating biologic medicines
No salary listed
Hyderabad, Telangana, India
In Person
Bachelor's, Master's
 Biology & Biotech (1) |
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- A BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or another related quantitative or scientific subject.
- At least 4 years of statistical programming experience in a clinical development environment.
- Familiarity with the drug development life cycle and strong skills in manipulating, analyzing, and reporting complex clinical trial data.
- Ability to perform complex statistical programming and related tasks.
- Ability to deliver quality outputs and deliverables within challenging timelines.
- Ability to work effectively on multiple tasks or projects across therapeutic areas.
- Ability to work effectively in a globally dispersed team environment with cross-cultural partners.
- Working knowledge of current CDISC SDTM standards and familiarity with CDISC ADaM and Define standards, with the ability to implement them.
- In-depth knowledge of SAS/STAT packages.
- Familiarity with data quality and compliance-check tools.
- Excellent oral and written English communication skills.
- Analyze and report clinical trial data using SAS and/or R.
- Create and validate complex SDTM, ADaM, and other safety and efficacy analysis datasets.
- Create and validate complex safety and efficacy tables, listings, and figures.
- Prepare statistical programming specifications.
- Prepare statistical programming-related documents for regulatory submissions.
- Maintain tracking and validation documentation.
- Collaborate with cross-functional team members and create or validate complex programs for checking data quality.
- Interact and collaborate with study team members from other functions globally.
- Assist with some Study Lead Programmer tasks or serve as a backup Study Lead Programmer.
- 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.
- Prior regulatory submission experience for drug approval.
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 reached $10.1 billion, and guidance rose to $38.2-$39.4 billion.
- Repatha sales jumped 37% to $953 million, with Uplizna up 90%.
- A federal judge blocked Colorado's Enbrel cap, preserving U.S. pricing flexibility.
What critics are saying
- FDA proposed withdrawing Tavneos on April 27, 2026, after data manipulation findings.
- Novartis pelacarsen failed Phase 3 in 2026, raising Amgen's olpasiran outcomes bar.
- Colorado's Enbrel price-cap fight continues on appeal, threatening legacy cash flow through 2027.
What makes Amgen unique
- Repatha, Evenity, Uplizna, and Tezspire diversify growth beyond Enbrel and Prolia.
- Amgen's 7,297-patient OCEAN(a)-Outcomes gives olpasiran a large cardiovascular readout.
- Hyderabad's Genome Valley center expands Amgen's R&D footprint with data-driven discovery.
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Company News
Amgen faces heightened scrutiny for its experimental heart drug olpasiran after rival Novartis's pelacarsen failed to reduce major cardiovascular events in a Phase 3 trial, despite successfully lowering lipoprotein(a) levels. The setback demonstrates that improving laboratory biomarkers may not translate to better patient outcomes. Amgen's OCEAN(a) outcomes study has enrolled 7,297 participants and is tracking heart-related deaths and procedures over roughly five years. While olpasiran uses a different design and may target different patients, pelacarsen's failure removes assumptions about the commercial value of lowering Lp(a). Amgen's shares traded at $437.23, sitting 19.54% above its estimated fair value of $365.76. The company reported $10.1 billion in second-quarter revenue and $3.5 billion in free cash flow.
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.