Senior Counsel (Gtm Legal)

Gong; Gerona; Remote; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Remote work

Job summary

Gong is seeking a Senior/Principal Statistical Programmer (SAS + R) to join our remote team. You will work on clinical development programs across therapeutic areas, with sponsor-dedicated support from Cytel and CRO oversight to ensure high-quality data deliverables.

You will generate SDTM, ADaM specifications and define.xml, develop SAS and R programs for datasets, listings, tables and graphs, and assist with regulatory submissions and DSURs while following FDA guidelines and GCP.

Qualifications

• Senior level statistical programmer with extensive clinical trial experience.
• Experience delivering SDTM/ADaM specifications and datasets.
• Oversight of CRO programmers to ensure quality and timelines.
• Develop SAS and R programs for listings, tables, and graphs.
• Familiarity with FDA regulations and GCP in submissions.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and graphs.
• Deliver high-quality statistical programming results and maintain programs.
• Oversee CRO's statistical programming deliverables across studies.
• Support preparation of CSRs, regulatory submissions, publications, DSUR, and exploratory analyses.
• Contribute to standards for programming tools and macros.
• Assist CRF development, edit checks, and data validation plans.
• Provide review.

Skills

SAS

R

Clinical trial programming

SDTM/ADaM specifications

Data analysis

CRO oversight

FDA guidelines

Tools

SAS

R

define.xml

CDISC SDTM/ADaM

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