Associate Director, Statistical Programming

About the role

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.
• 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 study 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; 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; 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; identify the macros or tools that will facilitate programming 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; 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

• Bachelor's Degree from an accredited institution in a science or technical field preferred; Master's Degree preferred.
• 10+ years of experience with a Bachelor’s degree, or 7+ years with a Master’s degree, in statistical programming supporting clinical trial