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Zusammenfassung

Cytel Inc. is seeking a Senior/Principal Statistical Programmer SAS + R for a remote, sponsor-dedicated role embedded with a pharmaceutical client.

You will lead SDTM/ADaM programming, complex listings, tables and graphs, and ensure high-quality results across multiple studies. The position requires 7+ years in statistical programming, expert SAS with CDISC (SDTM/ADaM/Define.xml), FDA/ICH regulation knowledge, and the ability to work independently while guiding CROs and collaborating with

Qualifikationen

• At a minimum bachelor's degree in computer science, data science, mathematics, or statistics major preferred
• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or similar
• 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 and strong leadership skills

Aufgaben

• Generate SDTM, ADaM specifications, datasets, reviewers' guide and define.xml files for multiple studies
• Develop SAS programs which 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 CRO's programming deliverables for multiple studies to ensure high-quality and timely delivery
• Support the preparation of clinical study reports, regulatory submissions, publications, and exploratory analyses
• Understand and follow FDA regulations affecting reporting of trial data
• Contribute to standards for programming tools, outputs, and macros
• Participate in CRF development, edit check specs, and data validation plans
• Provide review/author data transfer specifications for external vendor data
• Collaborate with internal/external functions to meet timelines and goals
• Provide review/author SOPs and Work Instructions related to programming practices

Kenntnisse

SAS programming

Leadership

Independence

Regulatory knowledge

R

Python

Java

Shiny

Unix/Linux

Git

Ausbildung

Bachelor's degree in computer science

Bachelor's degree in data science

Bachelor's degree in mathematics

Bachelor's degree in statistics

Tools

SAS

R

Python

Java

Shiny

Unix/Linux

Git

Jobbeschreibung

Senior/Principal Statistical Programmer SAS + R (Remote)

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

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.

Responsibilities

• 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

Qualifications

At a minimum bachelor's degree in computer science, data science, mathematics, or statistics major preferred

7+ 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

Preferred Qualifications

• Prior work experience with pharmacokinetic data and the neuroscience field,
• proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)

#LI-KO1

Cytel Inc. is an Equal Employment / Affienative 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.