Senior Manager, Statistical Programming (m/f/d)

Daiichi Sankyo Co.; France; Hybride; EUR 110 000 - 160 000; Plein temps

Résumé du poste

Daiichi Sankyo is seeking a Senior Manager, Statistical Programming to provide technical support to project teams and oversee outsourced programming activities. The role focuses on SDTM/ADaM datasets, TLFs, and regulatory submission readiness, with a drive to elevate efficiency and quality across the programming function.

Initial responsibilities include leading SDTM/ADaM reviews, developing standard templates and macros, and guiding internal programmers and vendors.

Qualifications

• 10+ years of experience in statistical programming supporting clinical trial analysis
• Experience with SAS macro and system utility development preferred
• Advanced SAS programming and CDISC SDTM/ADaM implementation in trials preferred
• Strong understanding of regulatory submission requirements and data standards

Responsabilités

• Provide statistical programming support to project teams and external vendors
• Review SDTM/ADaM datasets and TLFs for regulatory submissions
• Develop templates, macros and tools to improve efficiency and reproducibility
• Lead programming strategy for integrated efficacy and safety analyses
• Maintain SDTM/ADaM datasets and TLF standards in clinical trial data analysis

Connaissances

SAS macro development

CDISC SDTM/ADaM

Statistical programming

Regulatory submissions

Vendor management

Formation

Bachelor's degree in science/technical field

Master's degree preferred

Outils

SAS

Description du poste

Senior Manager, Statistical Programming (m/f/d)

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

Location

Primary preferred location: France

Second location: Germany

Job Summary

The purpose of this job is to provide statistical programming technical support to DSI project teams on all statistical programming deliverables and programming submission. It will also improve Daiichi Sankyo programming efficiency by developing tools and macros and build up standard on SDTM/ADaM datasets, and TFLs.

Responsibilities

Supporting project lead on outsourced projects, act as statistical programming subject matter expert (SME) to support outsourced programming activities and be responsible for the programming technical decision. By guiding other internal programmer or by self, perform programmatic review of Study Date Tabulation Model (SDTM) and analysis (including Analysis Data Model (ADaM)) datasets as well as TLFs generated by statistical vendor, ensure correct and effective vendor programming implementation, and expedite the preparation of regulatory submissions.

Responsibilities include: make strategic programming decision and planning, review Case Report Form (CRF) annotation and SDTM dataset, identify data inconsistencies and support data review, review analysis dataset specifications and ensure correct interpretation of SAP, develop independent programs to validate stud level analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review study submission data package and ensure its quality and integrity. Provide hands-on statistical programming support to regulatory submission and help submission team in quick turnaround in response to regulatory agencies.

Responsibilities include: develop programming submission strategy, lead integrated analysis of efficacy and safety, generate submission data package, create TLFs to support submission Q&As, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting Develop DSI programming standard template on datasets and TFLs to improve efficiency and quality.

Responsibilities include: contribute to CRF and SDTM standard development, develop, implement, and maintain SDTM, ADaM dataset and TLF standard, develop sample programs to generate and validate SDTM, ADaM dataset and TLFs, support technical training and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis Develop and maintain necessary programming macros or tools to effectively support all programming needs.

Responsibilities include: identify the macros or tools that will facilitate programing efficiency, lead the macro or tool development by working with contractors or by self, and support the macro or tool implementation and maintenance Evaluate, assess and enhance DSI computing environment system.

Responsibilities include: continue assessing DSI new computing environment system for programming and analysis efficiency, identify system bug/issue and lead the activity to enhance the system, develop system training materials and work as the SME to support implementation, evaluate, request and approve system upgrades, and propose/develop system utilities

Qualifications

Education Qualifications
Bachelor's Degree an accredited institution in a science or in a technical field preferred Master's Degree preferred
Experience Qualifications
10+ years of experience with a Bachelor's degree, or 7+ years with a Master's degree, in statistical programming supporting clinical trial analysis within a pharmaceutical company or CRO.
Previous experience supporting SAS macro and/or system utility development preferred
Advanced working knowledge of all aspects of the SAS programming language used in clinical trials programming preferred
Advanced working knowledge of CDISC SDTM and ADaM, and extensive experiences of their implementation in clinical trials analysis preferred
Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials preferred
Knowledge of all phases of drug development, including early and late phase clinical development and submission preferred
Solid background in applied statistics preferred
Solid knowledge of new advanced statistical methods using SAS and R preferred
Advanced knowledge in database structures and set-up preferred

Why work with us? Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.