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Statistical Programming Jobs in Pennsylvania (NOW HIRING)

This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more projects. Accountability predominantly ...

This position provides high quality statistical programming deliverables for global stakeholders in Early Development Statistics and/or PK/PD Modeling and Simulation spanning all our Company ...

SAS and/or SQL programming experience Experience working with Patient-level and/or medical claims ... D. in Statistics, Mathematics or related field with two to five years of experience OR a Bachelor ...

The Statistical Analytical Programmer plays a key role in turning complex EMR-focused real-world ... This person will bring strong SAS programming experience and a practical understanding of ...

Responsibilities As a Statistical Programming Consultant, you will use your SAS and R programming skills to prepare SDTM and ADaM datasets, Tables, Listings, & Figures (TLFs), as well as create ...

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Statistical Programming information

See Pennsylvania salary details

$84.7K

$147.6K

$249.6K

How much do statistical programming jobs pay per year?

As of Jul 15, 2026, the average yearly pay for statistical programming in Pennsylvania is $147,645.00, according to ZipRecruiter salary data. Most workers in this role earn between $125,300.00 and $160,400.00 per year, depending on experience, location, and employer.

What are some common challenges faced by statistical programmers when collaborating with cross-functional teams in clinical research?

Statistical programmers in clinical research often work closely with biostatisticians, data managers, and clinical teams. A common challenge is ensuring clear communication regarding data requirements, analysis specifications, and timelines, as different teams may have varying priorities and technical backgrounds. Navigating frequent changes in study protocols or data standards can also require adaptability and strong project management skills. Building collaborative relationships and maintaining thorough documentation are key to overcoming these challenges and ensuring high-quality, reproducible results.

What is statistical programming?

Statistical programming involves using software tools and programming languages, such as R, SAS, or Python, to manage, analyze, and interpret large sets of data. Professionals in this field write code to perform statistical analyses, create data visualizations, and automate data processing tasks. Statistical programming is widely used in industries like pharmaceuticals, finance, public health, and research to support data-driven decision-making and ensure accurate results.

What are the key skills and qualifications needed to thrive as a Statistical Programmer, and why are they important?

To thrive as a Statistical Programmer, you need strong expertise in statistics, programming languages like SAS or R, and a background in mathematics or computer science. Familiarity with statistical software, clinical data management systems, and regulatory standards such as CDISC is typically required. Attention to detail, problem-solving abilities, and effective communication are vital soft skills for collaborating with cross-functional teams. These skills ensure accurate data analysis, regulatory compliance, and successful project delivery in data-driven environments.

What is the difference between Statistical Programming vs Data Analysis?

AspectStatistical ProgrammingData Analysis
Primary FocusDeveloping and implementing statistical models and algorithmsInterpreting data to identify trends and insights
Skills & ToolsProgramming languages (SAS, R, Python), statistical methodsData visualization, descriptive statistics, Excel, SQL
Work EnvironmentPharmaceutical, biotech, or research settingsBusiness, marketing, healthcare sectors
CertificationsOften requires statistical or programming certificationsMay include data analysis or business analytics certifications

While both roles involve working with data, Statistical Programming primarily focuses on creating statistical models and algorithms using programming languages, often in research or clinical settings. Data Analysis emphasizes interpreting data to generate insights for decision-making across various industries. Understanding these differences helps professionals choose the right career path or job focus.

What are the most commonly searched types of Statistical Programming jobs in Pennsylvania? The most popular types of Statistical Programming jobs in Pennsylvania are:
What cities in Pennsylvania are hiring for Statistical Programming jobs? Cities in Pennsylvania with the most Statistical Programming job openings:
Infographic showing various Statistical Programming job openings in Pennsylvania as of July 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $147,645 per year, or $71 per hour.
Sr. Director, Biostatistics & Statistical Programming

Sr. Director, Biostatistics & Statistical Programming

Ocugen Inc

Malvern, PA โ€ข On-site

Other

Posted 22 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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