Statistical Programming Lead, Clinical Data Management, R&D, Orion Corporation

Orion Corporation; Cambridge (MA); Hybrid; USD 130,000 - 230,000; Full time

Job summary

Orion Corporation is seeking a Statistical Programming Lead to guide oncology programming for Phase I–III programs. You will provide hands‑on leadership, ensure CDISC standards, and deliver submission‑ready outputs in collaboration with Biostatistics, Data Management and Regulatory Affairs.

The role reports to the Head of Clinical Development Data Services and may be based in Cambridge (MA) or Cambridge (UK). A focus on automation and AI‑assisted programming is encouraged.

Qualifications

• This role requires a hands‑on programming lead for clinical studies and regulatory submissions.
• Deep knowledge of CDISC standards (SDTM/ADaM) and submission requirements.
• Experience with automation, standardization and process improvements in programming.

Responsibilities

• Lead statistical programming for oncology studies from startup to regulatory submission.
• Translate study objectives and submission requirements into executable deliverables.
• Develop and validate SDTM, ADaM, TLFs, and define.xml files.
• Ensure high‑quality, on‑time, regulation‑compliant outputs.
• Mentor programmers and drive tooling, macros, and best practices.

Skills

SAS programming

Base SAS

Macro programming

SQL

R or Python familiarity

CDISC SDTM/ADaM know‑how

Regulatory submissions

Automation & process improvement

Technical leadership

Education

Bachelor's or Master’s in Statistics/Biostatistics/CS/Math

Advanced degree preferred

Tools

R

Python

define.xml tooling

Job description

Statistical Programming Lead, Clinical Development Data Services, R&D, Orion Corporation

and 1 more

and 1 more

Job Description

You will join a growing oncology-focused Data Sciences function and provide hands‑on leadership and technical oversight for statistical programming activities supporting oncology drug development programs across Phase I–III clinical development. Reporting to the Head of Clinical Development Data Services, this role is responsible for delivering high-quality, regulatory‑compliant programming outputs that support clinical development, regulatory submissions, and study decision-making.

This role partners closely with Biostatistics, Data Management, Clinical Development, Regulatory Affairs, Medical Writing, and external service providers to execute programming plans, apply programming standards, support submission readiness, and ensure efficient delivery of programming outputs across studies and programs.

Responsibilities

• Serve as the Statistical Programming Lead for assigned oncology studies and programs, providing hands‑on technical leadership from study startup through regulatory submission.
• Represent Statistical Programming on cross‑functional study and program teams and translate study objectives, SAPs, and submission requirements into executable programming deliverables.
• Lead and contribute to the development, validation, QC, and delivery of SDTM, ADaM, TLFs, define.xml files, reviewer guides, and other submission‑related programming deliverables.
• Ensure programming deliverables are completed with high quality, on schedule, and in compliance with regulatory requirements and company standards.
• Contribute to the development, maintenance, and implementation of programming standards, tools, templates, macros, and best practices.
• Apply subject matter expertise in CDISC standards, regulatory submission requirements, and programming methodologies to ensure traceable, reproducible, and submission‑ready deliverables.
• Collaborate with Biostatistics to implement Statistical Analysis Plans, mock TLFs, and reporting requirements, ensuring consistent and accurate statistical deliverables.
• Support regulatory filing activities, including development and quality review of programming deliverables for NDA, BLA, and MAA submissions.
• Drive continuous improvement, automation, and appropriate use of AI‑assisted programming tools to improve programming efficiency, quality, traceability, and scalability.
• Provide technical guidance, mentoring, and quality review support to programmers, as needed.

This role can be based in Cambridge (MA) or in Cambridge, UK and reports to Head of Clinical Development Data Services.

What you can expect from us

At Orion Pharma, your work impacts millions of lives around the world. With us, you get to work on challenges that matter and see the difference your work makes every day. We believe our people are the key to our success, which is why we invest in your continuous learning.

Our innovative products are world‑class, and we take sustainability and ethics seriously. Rooted in our Nordic heritage, we value teamwork, low hierarchies, and a culture where every voice is heard.

We are builders of well‑being and offer jobs with a clear purpose: helping people live their lives to the fullest.

Please visit our website to find further information about our values and Orion as an employer https:

Requirements

• Bachelor's, Master's, or equivalent degree in Statistics, Biostatistics, Computer Science, Mathematics, or related quantitative discipline.
• 10+ years of statistical programming experience within the pharmaceutical or biotechnology industry, oncology preferred.
• Demonstrated experience serving as a hands‑on programming lead for clinical studies and regulatory submission activities.
• Strong expertise in SAS programming, including Base SAS, Macro programming, SQL, and clinical reporting.
• Experience with R, Python, or other modern programming languages is desirable.
• Deep knowledge of CDISC standards, including SDTM, ADaM, define.xml, controlled terminology, and submission requirements.
• Experience supporting global regulatory submissions and interactions with health authorities.
• Strong understanding of clinical trial processes, GxP requirements, and industry best practices.
• Experience implementing automation, standardization, and process improvement initiatives.
• Interest in emerging technologies and practical applications of AI‑assisted programming and automation tools.
• Excellent communication, collaboration, technical leadership, and problem‑solving skills.

The expected annual salary range for this position is USD130,000–230,000 for U.S.-based candidates, depending on skills, experience, and job‑related qualifications. For UK‑based candidates, compensation will be aligned with Orion’s salary range for the applicable grade.

Orion’s pharmaceutical innovations are created within its R&D organization. We employ over 400 top professionals in the field of drug discovery and development. We work globally: in Espoo and Turku in Finland, in Nottingham and Cambridge in the UK, and in Cambridge, MA, USA. Orion R&D and the Innovative Medicines business division are dedicated to making a transformation to become a global player in the pain and oncology therapy areas.

About Us

Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well‑being for over a hundred years.

We’re home to more than 4,000 Orionees around the world, and we’re proud to be known as a responsible employer and a great place to work. At Orion Pharma, people are truly valued and trusted, encouraged to grow, and supported by a culture where every voice is heard. We appreciate each other, strive for excellence, and build the future.

Together we develop, manufacture, and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Our extensive portfolio includes proprietary and generic medicines as well as consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion Pharma are used to treat cancer, neurological diseases, respiratory diseases, and more.

We offer careers with a clear purpose: empowering people to live their lives to the fullest.

• Locations One Broadway, Cambridge, Massachusetts, 02141, US The Bennett building B930 Babraham Research Campus, Cambridge, CB22 3AT, GB (Hybrid)