Associate Director Biostatistics in Bernards, NJ at DSI

Date Posted: 5/16/2018

Job Snapshot

Job Description

About Daiichi Sankyo Cancer Enterprise

The vision 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 Franchise, 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

Position leads complex studies in study design, statistical analysis and interpretation of results with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to Health Authorities globally with some supervision. This position also guides contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses. Additionally, this position interacts with study teams, as well as statisticians and programmers at CROs. This position works under some supervision to solve complex study problems.

Responsibilities

Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. Acts as main statistical contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.

Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.

CRO / Vendor Oversight: Review CRO/vendor proposal and budget. Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies. Ensures deliverables are accurate and delivered according to the timelines.

Global Health Authority Interaction / Negotiation: Contributes to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meeting or teleconferences with Health Authorities

Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.

Qualifications:

Education and Experience
  • PhD in statistics or biostatistics
  • Minimum 7 years relevant experience in the pharmaceutical industry
Competencies
  • Strong knowledge of statistical methodologies, current drug development trends, and regulatory environments.
  • Significant knowledge of pharmacology, clinical research, and medical terminology and use it for study design and results interpretation.
  • Strong analytical and problem solving skills and able to provide guidance to lower level biostatisticians in solving problems.
  • Able to identify and investigate issues and causes independently and formulate potential solutions
  • Able to develop and execute strategic plans for drug or non-drug projects
  • Able to prioritize multiple tasks, develop instructions and manage vendors in completing the deliverables with high quality according to timelines, and provide recommendations to improve process
  • Compliant with internal and external compliance practice to ensure integrity of work and suggest innovative approaches to improve compliances and processes
  • Excellent programming skills in SAS and/or R and working knowledge of software such as nQuery, East, etc.
  • Excellent oral and written communication skills.
  • Working knowledge of clinical trial methodologies.
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.