Ingeniero/A Piping Senior

Grupo Lantania; Sevilla; Remote; EUR 80,000 - 110,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on pharmaceutical clinical development programs. You will implement reporting and analysis activities, generate SDTM/ADaM specs, and lead CRO programming deliverables with minimal supervision.

You will contribute to study reports, regulatory submissions, and exploratory analyses, while adhering to FDA regulations and GCP guidelines. A strong SAS background and experience with R are essential.

Qualifications

• Bachelor's degree in CS/DS/Math/Statistics preferred
• 7+ years as Statistical Programmer in Biotech/Pharma Clinical Development Biometrics
• Exceptional SAS programming skills in clinical development environments

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies
• Develop SAS programs to generate datasets, listings, tables, and graphs
• Deliver high-quality statistical programming results with SAS and/or R
• Oversee CROs' programming deliverables to meet timelines
• Support preparation of clinical study reports, regulatory submissions and analyses
• Follow FDA regulations and GCP for electronic submissions
• Contribute to standards for programming tools and methodologies
• Develop data transfer specifications with external vendors
• Collaborate across internal and external teams to meet project goals
• Prepare SOPs and work instructions for statistical programming practices

Skills

SAS programming

R programming

Biostatistics

Clinical data reporting

Education

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

Tools

SAS

R

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.

• 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