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Principal Statistical Programmer

Cytel

United Kingdom

On-site

GBP 60,000 - 100,000

Full time

11 days ago

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Job summary

Join a forward-thinking company as a Principal Statistical Programmer, where you'll play a crucial role in advancing patient treatment through innovative clinical development programs. This exciting opportunity allows you to work independently, providing expert support while collaborating with global pharmaceutical clients. You'll be responsible for generating high-quality statistical programming outputs, ensuring compliance with FDA regulations, and leading programming efforts. If you're passionate about making a difference in the healthcare industry and possess exceptional SAS skills, this role is perfect for you!

Benefits

Consistent training and development

Support for career growth

Flexible working arrangements

Health and wellness programs

Qualifications

8+ years experience in statistical programming in clinical development.
Exceptional SAS programming skills and expertise in clinical environments.
Experience with regulatory submissions and FDA interactions.

Responsibilities

Generate SDTM, ADaM specifications, and datasets for multiple studies.
Develop SAS programs for datasets, listings, and complex graphs.
Oversee CRO deliverables to ensure high-quality outcomes.

Skills

SAS Programming

Statistical Analysis

CDISC Standards

Clinical Trial Methodologies

FDA Regulations

Communication Skills

Leadership Skills

Education

Bachelor's Degree in Computer Science

Bachelor's Degree in Data Science

Bachelor's Degree in Mathematics

Bachelor's Degree in Statistics

Tools

SAS

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Principal Recruiter - Global Talent Acquisition at Cytel

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:

This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel. 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 senior statistical programmer who will work on clinical development programs on different therapeutic areas and participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner. This individual will be responsible for implementing all reporting and analysis activities for the Sponsor clinical trials.

As a Principal Statistical Programmer, your responsibilities will include:

Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), 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 CRO’s 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
Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.
Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
Participate in the development of CRFs, edit check specifications, and data validation plans
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
Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices

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
8+ 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 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
Must be able to work independently
Outstanding communication skills (written and verbal) and strong leadership skills

Seniority level

Seniority level
Mid-Senior level

Employment type

Employment type
Full-time

Job function

Job function
Consulting
Industries
Pharmaceutical Manufacturing

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