Principal Statistical Programmer (FSP Remote)

Cytel; Springfield (IL); À distance; USD 130 000 - 180 000; Plein temps

Résumé du poste

Cytel is seeking a Principal Statistical Programmer to work fully embedded with a sponsor client, delivering SDTM/ADaM, datasets, and reports while ensuring regulatory readiness.

You will lead SAS programming across studies, oversee CRO deliverables, and contribute to study reports and regulatory submissions, requiring 7+ years in biostatistics programming and strong independent work and leadership.

Qualifications

• Bachelor degree in computer science, data science, mathematics or statistics.
• 7+ years of experience as a Statistical Programmer on Biotech/Pharma development biometrics.
• Exceptional SAS programming skills and experience with statistical programming procedures in a clinical setting.
• Extensive CDISC standards experience (SDTM, ADaM, Define.xml) and regulatory knowledge.
• Experience supporting regulatory submissions and engaging with FDA or global authorities.
• Ability to work independently and lead effectively.
• Excellent written and verbal communication and leadership skills.

Responsabilités

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies.
• Develop SAS programs to create datasets, complex listings, tables, and graphs.
• Deliver high-quality SAS and/or R programs tailored to development programs.
• Oversee CRO programming deliverables across studies to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, DSURs and analyses.
• Understand FDA regulations affecting reporting of trial data.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit check specs, and data validation plans.
• Provide review/author data transfer specifications for external vendor data.
• Collaborate with internal/external partners to meet project timelines and goals.
• Review/author SOPs and Work Instructions for statistical programming practices.

Connaissances

SAS programming

Independent work

Leadership

Communication

Formation

Bachelor's degree in computer science / data science / mathematics / statistics

Outils

CDISC standards (SDTM/ADaM)

Define.xml

SAS

R

Python

Unix/Linux

Git

Description du poste

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.

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

• 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 (nice to have)

• 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)

Cytel Inc. is an Equal Employment / Affiantative 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.