Principal Statistical Programmer FSP

Cytel; Columbus (OH); On-site; USD 120,000 - 180,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer fully embedded with a pharmaceutical client in Columbus, OH. You will drive SDTM/ADaM deliverables, define.xml, and complex listings with independence and leadership.

The role requires 9+ years in biotech/pharma biometrics, strong SAS and R skills, and extensive CDISC experience, delivering high-quality results on regulatory submissions.

Qualifications

• 9+ years as Statistical Programmer in Biotech/Pharma Clinical Development Biometrics Team or similar.
• Experience supporting drug development, medical device development, or intervention studies.
• Exceptional SAS/R programming skills for clinical development environments.
• Extensive CDISC (SDTM/ADaM/Define.xml), medical terminology, FDA/ICH regulation knowledge.
• Experience supporting regulatory submissions and interactions with FDA/global authorities.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml for multiple studies.
• Lead SAS programs to generate datasets, listings, tables and graphs.
• Deliver high-quality statistical programming results and maintain SAS/R programs.
• Oversee programming deliverables for multiple studies to meet timelines.
• Contribute to clinical study reports, regulatory submissions and exploratory analyses.

Skills

SAS programming

R programming

Leadership

Communication

Independent worker

Education

Bachelor’s degree in CS/Math/Statistics

Tools

CDISC SDTM/ADaM

Define.xml

SAS (general)

Job description

Sponsor-dedicated:

Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Principal Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

Position Overview:

The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members. We are looking for a highly experienced statistical programmer who will work on clinical development programs on different therapeutic areas and participate in overseeing programmers to ensure that data summaries are delivered in a consistent, high-quality manner. This individual will forge a long term relationship with the client, starting with study level programming responsibilities before building into leadership positions. The successful candidate will show proven leadership through technical expertise and has the ability to share knowledge and inspire others. Experience with R and an openness to learning and adopting new technologies will support the position.

As a Principal Statistical Programmer, your responsibilities will include:

• Generating SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
• Understand and follow FDA regulations which affect the reporting of clinical trial data, with experience supporting multiple FDA submissions across a broad range of programming activities.
• Lead and support the development of SAS programs to generate datasets, complex listings, tables, and complex graphs
• Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs’ needs
• Participate in overseeing statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines
• Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses
• Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Provide review and/or author data transfer specifications for external vendor data
• Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals

Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:

• At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred
• 9+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies
• Exceptional SAS/R programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment
• Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation
• Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities
• A drive to support immediate delivery demands while helping the organization adopt new technologies, standards, and ways of working.
• Must be able to work independently
• Outstanding communication skills (written and verbal) and strong leadership skills

Preferred Qualifications (nice to have)

• Proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)

Cytel Inc. is an Equal Employment / Affiliated Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.