Farmacéutico/A - Tardes - Ft Mario Cabré

Farmacias Trebol; Madrid; Remote; EUR 90,000 - 120,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R (Remote) to work with a sponsor client within one of our pharmaceutical partners. You will independently drive programming activities, develop SDTM/ADaM datasets, tables, and figures, and oversee CRO deliverables to ensure high quality and timely submissions.

The role requires 7+ years in Biotech/Pharma programming, strong SAS and R skills, and substantial CDISC and regulatory experience.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma clinical development.
• Exceptional SAS programming skills and experience in clinical development environments.
• Extensive experience with CDISC standards (SDTM/ADaM/Define.xml) and regulatory guidelines.
• Experience supporting regulatory submissions and interactions with FDA/global authorities.
• Ability to work independently and lead others; strong written and verbal communication.

Responsibilities

• Generate SDTM/ADaM specs, datasets, reviewers' guides, and define.xml for multiple studies.
• Develop SAS programs for datasets, listings, tables, and graphs.
• Deliver high-quality SAS and/or R programming outputs tailored to trials.
• Oversee CRO programmers to ensure high-quality deliverables within timelines.
• Support preparation of clinical study reports, regulatory submissions, and publications.
• Conform to FDA regulations and GCP for electronic submissions.
• Contribute to standards for tools, outputs, and macros.
• Collaborate with CROs and vendors to meet project goals.
• Develop data transfer specifications and SOPs in collaboration with teams.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

Regulatory submissions

Clinical trial data

Leadership

Communication

Independent work

Unix/Linux

Git

Education

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

Tools

Python

Java

Shiny

Markdown

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)

#LI-KO1

Cytel Inc. is an Equal Employment / Affirmative 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.

Madrid, Spain
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Sofia, Bulgaria
Bucuresti, Romania
Full time
R

**Job Overview**
Individual contributor with advanced knowledge acquired from at least 8 years of relevant industry experience. Working independently with limited supervision, the individual will provide strategic regulatory expertise and leadership for clinical trial applications and lifecycle management activities, with a strong focus on EU Clinical Trials Regulation (CTR) submissions and Clinical Trials Information System (CTIS) management.

• Act as Regulatory Global Team Leader for regulatory projects and/or serve as Regulatory Project Manager for stand-alone projects
• Lead the preparation, review, and submission of regulatory documentation, ensuring high quality and compliance with applicable regulations and guidelines
• Provide strategic regulatory advice to clients, including EU submission strategy, Reporting Member State (RMS) selection, scientific advice planning, and lifecycle management activities
• Lead and support EU CTR submissions, including initial CTA submissions, substantial modifications, Requests for Information (RFIs), and CTIS lifecycle activities
• Manage communications and interactions with regulatory authorities, including support for and participation in agency meetings.
• Build and maintain strong client relationships, acting as a trusted advisor on regulatory matters and proactively resolving issues
• Manage project timelines, deliverables, budgets, and out-of-scope activities to ensure successful project execution and financial performance
• Mentor and provide guidance to junior colleagues, including review of regulatory documentation and support for training and professional development
• Support business development activities, including travelling to and participating in bid defense meetings and client presentations
• Contribute to the development, revision, and review of regulatory and cross-functional Standard Operating Procedures (SOPs)
• Support global, regional, and cross-functional regulatory initiatives and process improvement activities
• Remain current with regulatory intelligence, evolving regulations, and industry best practices
• Perform additional duties as assigned to support business and departmental objectives

**Qualifications**

• Bachelor's Degree in Life Sciences or a related discipline required
• Master's Degree in Life Sciences or a related discipline preferred

**Experience**

• Minimum of 8 years of regulatory affairs experience within the pharmaceutical, biotechnology, CRO, or related industry
• Minimum of 2 to 3 years of hands-on EU CTR and CTIS experience, including preparation, review, and submission of Part I initial Clinical Trial Applications (CTAs)
• Demonstrated experience managing CTIS lifecycle activities, including RFIs, substantial modifications, and ongoing trial maintenance
• Experience interacting with Reporting Member States (RMS) and other European regulatory authorities
• Proven experience advising clients on EU regulatory strategy, including RMS selection, submission planning, and scientific advice strategy
• Advanced understanding of EU clinical trial regulations, guidance documents, and CTIS requirements
• Strong understanding of regulatory documentation requirements across different therapeutic areas, development stages, and product modalities
• Experience with combination product trials is advantageous
• Experience in regulatory strategy development, timeline planning, budget management, and documentation gap assessments
• Ability to independently manage multiple projects and priorities while meeting challenging timelines
• Strong project leadership and stakeholder management skills
• Excellent written and verbal communication skills, including preparation of high-quality regulatory documents and client-facing presentations
• Ability to establish and maintain effective relationships with clients, colleagues, and regulatory authorities
• Proficiency in Microsoft Office and relevant regulatory systems and publishing tools
• Applicable certifications and licenses as required by local regulations and business needs
• Willingness to support cross-functional and global initiatives as required

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**The Position** ...

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