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Ocugen Jobs (NOW HIRING)

Business Development Associate

Malvern, PA ยท On-site

$43K - $59K/yr

Position Summary The Business Development Analyst will support Ocugen's business development efforts by providing analytical, financial, and strategic support across potential partnerships, licensing ...

Business Development Associate

Malvern, PA ยท On-site

$43K - $59K/yr

Position Summary The Business Development Analyst will support Ocugen's business development efforts by providing analytical, financial, and strategic support across potential partnerships, licensing ...

Job Purpose The Executive Assistant will provide support to the CMO, as well as backup support to the CEO with diverse administrative duties and create a positive first impression of Ocugen. This ...

Job Purpose The Executive Assistant will provide support to the CMO, as well as backup support to the CEO with diverse administrative duties and create a positive first impression of Ocugen. This ...

VP/SVP Head of Clinical Development

Malvern, PA ยท On-site

$78K - $107K/yr

Position Summary The VP/SVP, Head of Clinical Development provides strategic, scientific/medical, and operational leadership across Ocugen's clinical development programs. This individual will lead ...

VP/SVP Head of Clinical Development

Malvern, PA ยท On-site

$78K - $107K/yr

Position Summary The VP/SVP, Head of Clinical Development provides strategic, scientific/medical, and operational leadership across Ocugen's clinical development programs. This individual will lead ...

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How much do ocugen jobs pay per hour?

As of Jun 25, 2026, the average hourly pay for ocugen in the United States is $26.34, according to ZipRecruiter salary data. Most workers in this role earn between $15.14 and $30.77 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Clinical Research Associate at Ocugen, and why are they important?

To thrive as a Clinical Research Associate at Ocugen, you typically need a degree in life sciences, experience in clinical trials, and knowledge of regulatory guidelines like GCP. Familiarity with electronic data capture (EDC) systems, trial management software, and relevant certifications (such as SOCRA or ACRP) is often required. Strong attention to detail, organizational skills, and effective communication help ensure studies run smoothly and data integrity is maintained. These skills are vital for supporting successful clinical trials, maintaining compliance, and advancing drug development in a regulated environment.

Is Ocugen a good company to work for?

Ocugen is a biotechnology company focused on developing gene therapies and vaccines, offering roles in research, manufacturing, and regulatory affairs. Employee reviews indicate mixed experiences, with some citing a collaborative environment and others noting limited advancement opportunities. As with any company, individual experiences vary based on role, department, and expectations.

What is the difference between Ocugen vs Bioinformatics Technician?

AspectOcugenBioinformatics Technician
Required CredentialsBiotech or related degree, possibly with regulatory knowledgeBachelor's in bioinformatics, biology, or related field; some roles may require coding skills
Work EnvironmentResearch labs, biotech companies, pharmaceutical settingsLaboratories, research institutions, biotech firms, often involving data analysis
Industry UsageBiotech, gene therapy, vaccine developmentGenomics, data analysis, research in biotech and healthcare

Ocugen focuses on vaccine and gene therapy development within biotech and pharmaceutical industries, often involving laboratory research and clinical trials. Bioinformatics Technicians primarily analyze biological data, supporting research and development in biotech and healthcare sectors. While both roles require a background in biology or related fields, Ocugen roles emphasize laboratory work and product development, whereas Bioinformatics Technicians focus on data analysis and computational tasks.

What are some typical challenges faced by professionals working at Ocugen in the biotechnology sector?

Professionals at Ocugen often navigate a fast-paced and highly regulated environment, where balancing innovation with strict compliance standards is essential. Working on breakthrough therapies can involve tight deadlines, cross-functional collaboration, and adapting to evolving clinical or regulatory requirements. Since teams are multidisciplinary, effective communication and flexibility are key to addressing unforeseen scientific or technical obstacles. Employees also need to stay current with the latest research and industry trends to contribute effectively to the company's mission.

What is Ocugen?

Ocugen is a biopharmaceutical company focused on developing gene therapies to cure blindness diseases and other medical conditions. The company specializes in innovative treatments for rare and underserved eye disorders, including inherited retinal diseases and age-related macular degeneration. Ocugen also works on vaccine development and has been involved in partnerships to bring COVID-19 vaccines to market. Their mission is to improve the quality of life for patients by offering breakthrough solutions in ophthalmology and regenerative medicine.

What jobs pay 2000 a day?

Jobs that can pay $2,000 a day typically include high-level roles such as specialized surgeons, senior corporate executives, successful entrepreneurs, or certain freelance consultants with in-demand skills. These positions often require extensive experience, advanced certifications, or a strong professional reputation, and may involve long hours or high responsibility levels.

Who is the CEO of Ocugen?

As of October 2023, the CEO of Ocugen is Shankar Musunuri. He co-founded the company and has been leading its strategic direction in biotechnology and vaccine development.

What is going on with Ocugen?

Ocugen is a biotechnology company focused on developing gene therapies and vaccines, including COVID-19 vaccine candidates. The company has been involved in research and clinical trials, and updates on its progress are typically shared through official press releases and regulatory filings.
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What cities are hiring for Ocugen jobs? Cities with the most Ocugen job openings:
What states have the most Ocugen jobs? States with the most job openings for Ocugen jobs include:
Infographic showing various Ocugen job openings in the United States as of June 2026, with employment types broken down into 100% Full Time. Highlights an 100% Physical job distribution, with an average salary of $54,791 per year, or $26.3 per hour.
Sr. Director, Biostatistics & Statistical Programming

Sr. Director, Biostatistics & Statistical Programming

Ocugen Inc

Malvern, PA โ€ข On-site

Other

Posted 2 days ago


Job description

Purpose
The Director, Biostatistics & Statistical Programming serves as Ocugen's most senior biometrics leader, providing executive-level scientific and operational oversight across all biostatistics and statistical programming activities in support of Ocugen's ophthalmology-focused gene therapy pipeline. As a core member of the R&D leadership team, this individual is accountable for the strategic direction, design, execution, and regulatory delivery of biometrics across Ocugen's portfolio including OCU400, OCU410, OCU410ST, and future development programs.
This role leads all biometrics contributions to late-stage clinical development, BLA and NDA submissions, and health authority interactions, ensuring delivery of high-quality, submission-ready datasets, analyses, and regulatory documentation compliant with global standards. The Senior Director will be a recognized expert in ophthalmic endpoints, retinal imaging assessments, and the statistical methodology specific to rare inherited retinal diseases and AAV-based gene therapies. This individual will shape critical development and regulatory decisions and serve as Ocugen's primary statistical authority in interactions with the FDA, EMA, and other global health authorities.
Responsibilities
Strategic & Executive Leadership
  • Serve as Ocugen's senior biometrics authority, shaping the strategic direction for all biostatistics and statistical programming activities across the R&D portfolio.
  • Translate corporate and product development goals into rigorous, operationally executable biometrics strategies that balance scientific defensibility, regulatory compliance, and speed of execution.
  • Represent Ocugen as the senior biometrics lead in interactions with the FDA, EMA, and other global health authorities - including BLA/NDA submission meetings, Type A/B/C meetings, and advisory committee preparations.
  • Provide authoritative statistical leadership for gene therapy development programs, with expertise in rare disease trial design, small patient populations, longitudinal assessments, and long-term follow-up.
  • Establish and maintain biometrics standards, SOPs, and governance aligned with GCP, ICH, CDISC, and evolving regulatory expectations for advanced therapies.
  • Contribute to R&D governance, portfolio prioritization, and executive-level strategic planning as a member of the senior leadership team.

Biostatistics Leadership - Late-Stage & Regulatory
  • Lead statistical design, analysis planning, interpretation, and reporting for all late-stage clinical programs, including Phase 2/3 trials and pivotal studies supporting BLA and NDA submissions.
  • Provide scientific leadership for protocol development, ophthalmic endpoint selection (BCVA, LLVA, full-field stimulus testing, ellipsoid zone integrity, microperimetry), sample size determination, randomization, and adaptive design considerations.
  • Oversee development, review, and final approval of Statistical Analysis Plans (SAPs) across all programs.
  • Serve as the primary statistical resource for Data Monitoring Committees (DMCs), interim analyses, executive-level data reviews, and governance committee presentations.
  • Ensure statistical methodologies are scientifically defensible, clinically interpretable, and aligned with current FDA and EMA regulatory expectations for ophthalmic gene therapies.
  • Lead statistical innovation efforts, including Bayesian adaptive designs, novel estimands (ICH E9 R1), natural history-informed analyses, and patient-level simulation approaches relevant to rare disease programs.

Statistical Programming Leadership
  • Provide strategic and hands-on operational oversight of all statistical programming activities, including CDISC-compliant SDTM and ADaM dataset development, TLF production, integrated summaries, and electronic regulatory submission deliverables.
  • Establish and enforce programming standards, validation procedures, and quality control processes consistent with inspection readiness and global regulatory compliance.
  • Direct oversight of CRO and statistical programming vendors, ensuring quality, timeliness, and regulatory defensibility of all deliverables.
  • Champion implementation of automation, modern programming tools, and operational efficiencies to improve quality and execution speed across programs.
  • Ensure all programming deliverables meet FDA and EMA eCTD submission requirements, including electronic Common Technical Document formatting standards.

Clinical Data Review & Development Decision Support
  • Partner closely with Clinical Development, Clinical Sciences, Medical Affairs, and Regulatory Affairs to interpret emerging clinical and biomarker data and inform program-level decisions.
  • Lead integrated reviews of efficacy, safety, imaging, and functional assessments - including retinal imaging (OCT, fundus), electrophysiology (ERG/mfERG), and visual function measures specific to inherited retinal diseases.
  • Present data analyses and strategic biometrics recommendations to C-suite leadership, Board of Directors, and external governance bodies.
  • Serve as an internal expert on the natural history of inherited retinal disease and gene therapy endpoints, providing scientific context for statistical interpretations.

Operational Excellence & Team Development
  • Build and develop Ocugen's internal biometrics function, including hiring, mentorship, and performance development of biostatistics and programming staff.
  • Drive accountability for external vendors and CRO partners; establish governance structures for vendor oversight and issue escalation.
  • Implement scalable, milestone-driven processes supporting current late-stage programs and future pipeline growth.
  • Maintain the highest standards of data integrity, quality, and regulatory defensibility across all programs.
  • Ensure perpetual inspection readiness in compliance with FDA 21 CFR Part 11, GCP, and global expectations for advanced therapy submissions.

Required
  • PhD or MS in Biostatistics, Statistics, Mathematics, or a related quantitative PhD or MS in Biostatistics, Statistics, Biometrics, or a related quantitative discipline; PhD strongly preferred.
  • 15+ years of progressive experience in biostatistics and/or statistical programming in biopharmaceutical development, with at least 5 years in a senior leadership role.
  • Demonstrated success leading biometrics activities supporting late-stage clinical development and regulatory submissions - including at least one BLA or NDA filing with FDA or equivalent global submission - with a strong record of successful health authority interactions.
  • Deep expertise in ophthalmology clinical development, including ophthalmic endpoints (BCVA, LLVA, FSST, microperimetry, EZ integrity on OCT), retinal imaging assessments, central reading center oversight, and ophthalmology-specific regulatory submission strategies.
  • Experience supporting gene therapy clinical development programs, preferably AAV-based or other viral vector platforms.
  • Expert-level knowledge of GCP, ICH E9/E9(R1), ICH E6, CDISC standards (SDTM, ADaM, DEFINE-XML), and FDA/EMA regulatory expectations for advanced therapies.
  • Demonstrated experience overseeing external statistical programming vendors and CROs in a late-stage, submission-critical environment.
  • Exceptional leadership, scientific communication, and cross-functional influencing skills; proven ability to operate effectively in a lean, agile biotechnology environment.

Preferred
  • Experience supporting rare inherited retinal disease (IRD) programs, including natural history-informed trial design and endpoint selection for diseases such as retinitis pigmentosa, Stargardt disease, or geographic atrophy.
  • Familiarity with FDA's guidance framework for rare disease drug development, including Accelerated Approval, Breakthrough Therapy Designation, and endpoint qualification processes.
  • Experience with Bayesian adaptive trial designs, estimand frameworks (ICH E9 R1), and novel statistical methods applicable to small patient populations.
  • Experience supporting FDA advisory committee (AdCom) preparations and presentations.
  • Prior experience operating as the senior biometrics' leader within a small-to-mid-stage biotechnology company, including direct involvement in building or scaling an internal biometrics function.

Working Conditions
Incumbent will primarily work Monday - Friday during normal business hours out of our Malvern, PA corporate headquarters. This position operates in an office setting, and jhob may require incumbent to be available outside of normal hours to handle priority business needs. We do not offer remote work for this role.
Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual's conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.

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About Ocugen

Sourced by ZipRecruiter

Industry

Biotechnology research and development

Company size

51 - 200 Employees

Headquarters location

Malvern, PA, US

Year founded

2013

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