Senior Manager Statistical Programming

hace 6 meses

All, España Daiichi Sankyo Europe A tiempo completo

Passion for Innovation. Compassion for Patients.

With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.

Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.

For our headquarters in Munich we are seeking highly qualified candidates to fill the position:

Senior Manager Statistical Programming (m/f/x)

The Position:

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.

 
Roles & 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, perform 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,

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