Ingeniero Electromecánico Senior

Estel Ingeniería Y Obras S.A.; Islas Baleares; Remote; EUR 70,000 - 110,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R to work remotely with one of our pharmaceutical clients. You will be responsible for delivering high-quality programming for clinical development programs and independent work with minimal supervision.

Responsibilities include generating SDTM and ADaM specifications, datasets, tables, listings, and graphs, supporting regulatory submissions, and overseeing CRO programming to ensure timely, compliant results across therapeutic

Qualifications

• Senior statistical programmer with extensive clinical trial experience.
• Proficient in generating SDTM/ADaM datasets, listings, and define.xml.
• Ability to supervise CRO programmers and ensure high-quality outputs.

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, and 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, DSURs, and exploratory analyses
• Understand and follow FDA regulations which affect the reporting of clinical trial data including GCP
• 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

Skills

SAS programming

R programming

CDISC SDTM/ADaM

GCP/FDA guidelines

CRO oversight

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