SAS PROGRAMMING DIRECTOR PARIS (H/F)

Paris, France

100k € per year

R&D Permanent contract Full-time

Language level

English - Spoken and written bilingual

Description

88BIOSCIENCE is a new Lifescience recruitment brand from 88JOBS, the multi-specialist recruitment platform based in Europe and Asia. Our mission is to provide a professional, friendly and overall, reliable service for those looking for work and companies looking for staff.

Today, 88BIOSCIENCE is looking for a SAS PROGRAMMING DIRECTOR.

The hiring company:

Our client is a pharmaceutical company specialized in building major clinical development programs (oncology, neurodegenerative diseases…).

The job responsibilities:

You will have to:

Ensure the integrity of programming and computing solutions for a global clinical drug development program.
Ensure the successful and timely delivery of the Investigator's Brochure (IB) and Development Safety Update Report (DSUR) every year.
Lead or support electronic submission preparation and review processes.
Oversee the complete execution of final production output, ensuring the delivery of high-quality and timely programming deliverables for Clinical Study Reports (CSRs) and regulatory submissions.
Collaborate with statisticians to develop project-level programming standards and ensure compliance with project-level, disease-area, and company standards. Provide support for the development of disease-area programming standards when necessary.
Ensure consistency and compliance with company standards in documents and specifications, including electronic Case Report Forms (eCRFs) and data structures, tables, listings, and figures for Phase I-III clinical trials and submission activities within the responsible drug project.
Program analysis datasets, pooled datasets, listings, tables, figures, and listings for Phase I-III clinical trials and regulatory submissions according to established specifications.
Prepare Case Report Tabulations as required for submission.
Collaborate with statisticians to develop and update project-level programming specifications for analysis datasets and pooled datasets (e.g., in Statistical Analysis Plans and Table, Listing, and Figure shells) for the clinical drug project.
Develop advanced MACROs for general use by programmers.
Maintain up-to-date advanced knowledge of programming software, such as SAS, R, and Splus.
Ensure quality control compliance and take responsibility for project records, including archiving of programming and associated documentation. Maintain audit readiness for quality programming deliverables for the drug project.

Profile needed

You are the person the hiring company is looking for if you have:

Education: Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences is required.
A minimum of 6 years of programming experience in the industry, including support for significant regulatory filings.
Proficiency in drug development processes, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data.
Broad expertise in statistical programming and the development of computing strategies.
In-depth understanding of clinical data structures (e.g., CDISC standards) and relational databases.
Demonstrated proficiency in using SAS to produce analysis datasets and Table, Listing, and Figure shells, as well as proficiency in other software tools and applications (e.g., MS Office, XML, Pinnacle 21).
Demonstrated ability to process upstream data (e.g., multiple data forms, workflows, electronic Data Capture, Study Data Tabulation Model) and provide deliverables to meet downstream requirements (e.g., Analysis Data Model, Table, Listing, and Figure shells, electronic submission components).
Proven ability to work effectively in a team environment with clinical team members.
Skills: SAS, MS Office, CDISC.

Other informations

Additional information, salary and benefits

Start date: as soon as possible
Type of contract: Permanent
Job type: full time
Salary : 100k € per year

6 days ago

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