Associate Director, Data Programmer in Bernards, NJ at DSI

Date Posted: 8/7/2018

Job Snapshot

Job Description

About Daiichi Sankyo Cancer Enterprise

The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.

Job Summary

The purpose of this job is to support project team on all statistical programming decision and planning, manage and oversee programming vendor deliverables, ensure programming deliverable quality, and expedite the preparation of regulatory submission. For a potential submission, it will lead a programming team to support submission programming activities, generate integrated analysis, and create submission data packages. It will also maintain institutional knowledge across Therapeutic Area (TA) compounds and support building up Daiichi Sankyo programming standard on datasets and TFLs to improve efficiency and quality.

Responsibilities

1. Act as statistical programming functional representative in project team to lead programming activity discussions and be responsible for the decision and implementation. By leading internal programming resources 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 vendor deliverable quality, 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, lead the development of 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.
2. Oversee statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines met. Responsibilities include: review and agree on vendor project timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor SDTM, analysis dataset and TLFs transfers for ongoing and complete trials, confirm data use and output quality, proactively ensure the resolution of programming related issues prior to database lock analysis, be accountable and verify completeness of study programming deliverables, maintain all required study programming documentation required for Trial Master File (TMF), and assess vendor performance.
3. For the submission compound, provide programming support to regulatory submission and help submission team in quick turnaround in response to regulatory agencies. Responsibilities include: plan 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
4. Maintain institutional knowledge across TA compounds and support building up TA programming standard on datasets and TFLs to improve efficiency and quality. Responsibilities include: contribute to CRF and SDTM standard development, support develop, implement, and maintain ADaM dataset and TLF standard, develop sample programs to generate ADaM dataset and TLFs, support training and ensure implementation of ADaM and TLFs standard in clinical trials analysis
5. Develop and maintain programming macros to effectively support early signal detection. Responsibilities include: work with Biostatistics member to define the requirements of efficacy data review, perform analysis, develop macros and support the internal data review and monitoring on an ongoing basis

Qualifications

Education
  • Bachelor's degree from an accredited institution in a technical field such as computer science or mathematics; Master’s degree in bio/statistics preferred
Experience
  • 10+ yrs (7-8 w/M.S. degree)
  • Proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming
  • Previous experiences supporting oncology compound development is highly preferred
  • Advanced working knowledge of all aspects of the SAS programming language used in clinical trials programming.
  • Advanced working knowledge of CDISC SDTM and ADaM, and extensive experiences of their implementation in clinical trials analysis
  • Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials.
  • Having knowledge of all phases of drug development, including early and late phase clinical development and submission
  • Having solid background of applied statistics
  • Solid knowledge of new advanced statistical methods using SAS and R
  • Knowledge in database structures and set-up
  • The candidate should have successfully provided programming expertise at the Project level for at least two global development projects that have been submitted to regulatory agencies
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.