Solutions Architect Especialista En Producto

Indra Group; Madrid; Remote; EUR 70,000 - 100,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on pharmaceutical client projects. The role focuses on SAS and R programming, SDTM/ADaM compliance, and regulatory submissions, with CRO oversight to ensure quality and timelines.

You will operate with minimal supervision, contribute to CRFs, data validation, and data transfer specs, and ensure adherence to FDA/ICH guidelines while collaborating across internal and external teams.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics
• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or similar
• Exceptional SAS programming skills in clinical development environments
• Extensive CDISC (SDTM/ADaM/Define.xml) knowledge and FDA/ICH regulatory familiarity
• Experience supporting regulatory submissions and interaction with regulatory authorities
• Ability to work independently and lead CRO programming deliverables

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml for multiple studies
• Develop SAS programs to generate datasets, listings, tables, and graphs
• Deliver high-quality SAS/R programs tailored to clinical development needs
• Oversee CRO programming deliverables to meet timelines
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs
• Follow FDA regulations and electronic submission guidelines

Skills

SAS programming

R programming

CDISC standards (SDTM/ADaM/Define.xml)

Regulatory submissions

Independent work

Leadership

Education

Bachelor's degree in computer science, data science, mathematics, or statistics

Tools

R

Python

Java

Shiny

Unix/Linux

git

Job description

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.
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 / Aff\aut; Actions

Cytel Inc. is an Equal Employment / Aff\aut; Actions. 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.