Full-Time
Associate Director
Statistical Programming
Posted on 10/2/2025
Biogen
5,001-10,000 employees
Develops therapies for neurological disorders
No salary listed
Waltham, MA, USA + 1 more
More locations: New York, NY, USA
Remote
 Biology & Biotech (2) |
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- Bachelor’s or Master’s degree in Computer Science, Statistics, Mathematics, or related field.
- Strong proficiency in SAS programming; experience with R or Python a plus.
- In-depth knowledge of CDISC standards (SDTM and ADaM), FDA/EMA regulatory requirements, and ICH guidelines.
- Strong attention to detail and commitment to producing high-quality, audit-ready deliverables.
- Excellent organizational and communication skills with a proactive, solution-oriented mindset.
- Ability to work effectively in a lean, cross-functional, start-up environment.
- Lead the development, validation, and documentation of statistical programming deliverables (e.g., SDTM, ADaM datasets, tables, listings, and figures) for clinical studies and regulatory submissions.
- Collaborate with internal teams and CRO partners to ensure quality, consistency, and compliance with CDISC standards and regulatory requirements.
- Serve as the primary programming lead across multiple studies or clinical programs.
- Develop and maintain programming standards, tools, and processes to support scalable clinical development.
- Provide strategic input to study design, data flow, and database structures from a programming perspective.
- Review and provide input on protocols, statistical analysis plans (SAPs), CRFs, and data specifications.
- Support preparation of regulatory documents including clinical study reports (CSRs), ISS/ISE, and responses to health authority questions.
- Partner with biostatistics, data management, medical writing, regulatory, clinical development, and clinical operations teams to ensure alignment of timelines and deliverables.
- Contribute to vendor selection, oversight, and performance management related to programming activities.
- Experience with eCTD submission programming and contributing to BLA/NDA/MAA filings preferred.
Biogen is a global biotechnology company focused on neuroscience. It discovers, develops, and delivers therapies for neurological disorders, such as multiple sclerosis and other neurodegenerative diseases. Its product process starts with research and development to identify potential drugs, followed by clinical testing and regulatory approval, ultimately leading to commercialization and patient treatment. Biogen differentiates itself through a long history (founded in 1978), a deep specialization in neuroscience, and an integrated pipeline that moves ideas from discovery to approved medicines, aiming to create value for shareholders while helping communities. The company’s goal is to advance therapies for neurological diseases to improve patients’ lives and generate sustainable value for stakeholders.
Company Size
5,001-10,000
Company Stage
IPO
Headquarters
Cambridge, Massachusetts
Founded
1978
Simplify's Take
What believers are saying
- Leqembi sales surged 74% to $168 million in Q1 2026, driving Alzheimer's growth.
- Non-MS products generate 45% of revenue, diversifying beyond multiple sclerosis franchise.
- Felzartamab Phase 3 readout in 2027 validates $5.6 billion Apellis and HI-Bio investments.
What critics are saying
- Multiple sclerosis sales stagnate at $957.5 million in Q1 2026 from Novartis Kesimpta competition.
- Spinraza revenue drops 12% to $374 million in Q1 2026 due to generic erosion.
- $5.6 billion Apellis deal incurs $1 per share charges, cutting 2026 EPS to $14.25-$15.25.
What makes Biogen unique
- Apellis acquisition adds Empaveli and Syfovre for immunology and rare kidney diseases.
- Felzartamab targets CD38 in Phase 3 trials for IgA nephropathy and membranous nephropathy.
- Alloy's AntiClastic ASO platform enhances antisense drug potency for undisclosed indications.
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Benefits
Remote Work Options
Professional Development Budget
Company News
Biogen Inc. to invest in felzartamab rights in Greater China through agreement with TJ Biopharma. Tuesday, April 21, 2026 Biogen Inc. has entered into a definitive agreement to invest in the exclusive rights to felzartamab held by TJ Biopharma in the Greater China region. Following the agreement, Biogen will hold exclusive global rights to the drug candidate, which is currently under Phase 3 clinical evaluation for several immune-mediated diseases. Under the terms of the deal, TJ Biopharma will receive an upfront payment of $100 million. The company is also eligible for up to $750 million in milestone payments linked to commercial and sales performance, taking the total potential value of the agreement to $850 million. In addition, TJ Bio will earn royalties in the mid-single-digit to low-double-digit percentage range on net sales in the Greater China region. Biogen plans to record the upfront payment as an acquired in-process research and development expense in the second quarter of 2026. As part of the transaction, Biogen will also take over milestone and royalty obligations tied to an earlier licensing agreement with MorphoSys, a subsidiary of Novartis. Biogen had earlier secured global rights to felzartamab, excluding Greater China, through its acquisition of HI-Bio in July 2024. The company has since initiated Phase 3 trials targeting conditions such as antibody-mediated rejection in kidney transplant patients, IgA nephropathy, and primary membranous nephropathy, with plans to expand into additional indications. The agreement builds on ongoing collaboration between the two companies. In April 2025, TJ Bio joined two global Phase 3 trials sponsored by Biogen, focusing on IgA nephropathy and primary membranous nephropathy in China. Both conditions are major contributors to kidney disease in the country, with a large patient population affected. Biogen will continue to lead clinical development in immunology, and will also take responsibility for manufacturing and commercial activities for felzartamab in the Greater China region. A biologics licence application for felzartamab, submitted by TJ Bio in December 2024 for the treatment of multiple myeloma, is currently under review by the National Medical Products Administration. Following approval, Biogen will oversee post-approval activities in the region, while TJ Bio will act as the manufacturing partner for this indication at its Hangzhou GMP plant.
Drugs from a text prompt, Wegovy pill competition dampens Lilly's surge. April 10, 2026 From designing drugs with a simple text prompt to running experiments guided by extended reality, a new wave of agentic AI is transforming the modern lab. Its editors discuss the latest autonomous systems accelerating biological discovery. In business deals, Gilead Sciences has acquired Tubulis in a transaction worth up to $5 billion, strengthening the buyer's position in antibody-drug conjugates for cancer. Correspondingly, Eli Lilly and Biogen are each making billion-dollar-plus bets, acquiring Centessa, a sleep disorder drug developer, and Apellis, known for its work in immunology and rare diseases. Its episode rounds out by unpacking the dynamic obesity drug market, where intensifying competition from Novo Nordisk's Wegovy pill is prompting Lilly to temper the 2026 sales outlook for its oral obesity drug, Foundayo. Listed below are links to the GEN stories referenced in this episode of Touching Base:
Biogen taps Alloy platform to push antisense drug pipeline forward. Stock score locked: want to see it? Benzinga Rankings give you vital metrics on any stock - anytime. Biogen Inc. (NASDAQ:BIIB) on Tuesday entered into an agreement with Alloy Therapeutics Inc. to accelerate the development of antisense therapies targeting multiple undisclosed indications. Waltham, Massachusetts-based Alloy will receive an upfront payment and stands to earn additional milestone-based compensation, along with tiered royalties on any commercialized products arising from the partnership. Expanding rna-targeted drug development. Alloy's AntiClastic ASO platform is designed to improve the effectiveness of antisense therapeutics by enabling drug developers to target disease pathways at the RNA level within cells. The approach seeks to address longstanding challenges in the field, particularly around drug potency and therapeutic index. Historically, antisense drugs have faced limitations due to poor biodistribution, which has constrained their clinical efficacy. Alloy's broader technology ecosystem. Alloy Therapeutics operates a diversified platform model aimed at accelerating drug discovery. Its ecosystem integrates multiple technologies, including computational and AI-driven tools, to enhance therapeutic development and optimization. The collaboration with Biogen reflects continued interest in leveraging advanced platforms to improve drug discovery efficiency and expand the potential of RNA-based therapeutics. In January 2025, Alloy Therapeutics inked a target-specific collaboration and license agreement for the use of their novel and proprietary AntiClastic Antisense Platform with Sanofi SA (NASDAQ:SNY) for a central nervous system (CNS) target. In return, Sanofi paid an upfront license fee and near-term preclinical milestone payments up to $27.5 million. Alloy is also eligible to receive discovery, development, and commercial milestone payments of over $400 million. Biogen expands portfolio with Apellis deal. Last week, Biogen agreed to acquire Apellis Pharmaceuticals Inc. (NASDAQ:APLS) for $41 per share in cash or approximately $5.6 billion. The acquisition is expected to enhance Biogen's growth portfolio in immunology and rare diseases. The deal consideration includes a contingent value right (CVR) for each share. It allows shareholders to receive two payments of $2 per share based on certain sales thresholds for Apellis. BIIB Stock Price Activity: Biogen shares closed at $172.34 on Monday, according to Benzinga Pro data. Everyone Bought NVIDIA. The Smart Money Is Now Buying What NVIDIA Needs to Run. The chip trade is crowded. Valuations are stretched. The investors who made money on Phase 1 of AI are already repositioning into the one thing every data center depends on: uninterrupted power. Natural gas and nuclear are the only sources that can deliver it at scale - and one small company just landed a deal to power multiple new hyperscale data centers. Posted In: Discover Private Market Opportunities Join 385,000+ Investors
Alloy Therapeutics has entered a collaboration and licence agreement with Biogen for use of its AntiClastic ASO Platform to develop antisense therapeutics against multiple undisclosed targets. Alloy will receive an upfront payment and is eligible for milestone payments and tiered royalties on resulting products. The AntiClastic ASO platform addresses potency and therapeutic index challenges that have historically limited antisense drugs due to biodistribution constraints. The technology combines improvements in primary sequence with proprietary spatial conformation of nucleic acids to enhance delivery to target RNA whilst mitigating inflammatory responses. Alloy Therapeutics is a biotechnology ecosystem company that provides access to AI-powered drug discovery platforms and scientific expertise across multiple therapeutic modalities, including antibodies, bispecifics, genetic medicines and cell therapies.
Biogen, a pioneer in neurological treatments, faces significant headwinds despite its 20.7% free cash flow margin. The company's sales have declined 6% annually over the past five years, with earnings per share falling 14.2% annually during the same period. Founded in 1978, Biogen develops therapies for multiple sclerosis, Alzheimer's disease, spinal muscular atrophy and rare diseases. However, its products face end-market challenges, and diminishing returns on capital suggest earlier profit pools are drying up. Trading at $177.40 per share, or 11.6x forward price-to-earnings, Biogen illustrates that strong cash flow alone doesn't guarantee superior returns when underlying business fundamentals weaken.