Senior Murex Mrb Developer — Market Risk

Bosonit group; Huelva; Remote; EUR 107,000 - 142,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R to work remotely on a sponsor-dedicated program for a global pharmaceutical client. You will develop SDTM/ADaM specifications, write SAS and R code, and ensure high-quality data outputs and regulatory submissions.

The ideal candidate has 7+ years in biostatistics programming, CDISC standards expertise, and the ability to work with CROs and cross-functional teams while following FDA/ICH guidelines.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years as Statistical Programmer in Biotech/Pharma Clinical Development Biometrics Team or related experience.
• Exceptional SAS programming skills for clinical development.
• CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulation knowledge.
• Ability to work independently and deliver high-quality results.

Responsibilities

• Generate SDTM and ADaM specifications, datasets, reviewer’s guides, and Define.xml files for multiple studies.
• Develop SAS programs to create datasets, complex listings, tables, and graphs.
• Deliver high-quality programming outputs and maintain SAS and/or R programs for clinical programs.
• Oversee CROs' programming deliverables to meet timelines and quality.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs.

Skills

SAS programming

CDISC SDTM/ADaM

Define.xml

Independent worker

Clinical development

Education

Bachelor's degree in CS/Math/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.

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 (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

What you’ll need

• 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