Senior Director, Biostatistics in Basking Ridge, NJ at DSI

Date Posted: 8/9/2020

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years & Counting!

With over 100 years of scientific expertise & a presence in more than 20 countries, Daiichi Sankyo & its 15,000 employees around the world draw upon a rich legacy of innovation & a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension & thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research & development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart & kidney diseases, & other rare diseases.

Job Summary:

This position serves as the Biostatistics lead supporting projects and activities of real world evidence (RWE). The incumbent will be responsible for providing statistical strategy, planning, group development for all RWE activities. The position is accountable for the statistical strategy and deliverable to support RWE activities in terms of time and quality. The position is also responsible for developing a statistical group, developing statistical expertise, promoting innovations, maintaining operational excellence and building efficient processes and standards for RWE. This position will represent the function in global RWE organization and is responsible for resource planning/allocation, timeline management and prioritization for statistical deliverables. The position is also accountable for people management, including performance and development of direct reports.

Responsibilities:

Statistical deliverables and analyses: Perform analyses and provides oversight on activities of data science by direct/indirect reports across the regional/global functions when assigned. Develops, directs, prioritizes, and monitors all assigned projects to ensure the timeline and quality. Monitor all project related activities against the standard procedures and policies. Leverage research capability using RWD by avoiding duplication use across functions and maximize efficiency of the use of RWD.

RWE Strategy: Reviews and provides leadership on the alignment of RWE strategy. Subject matter expert in RWE. Develop streamlined and consistent global RWE strategies throughout research, development, and post-marketing.

CRO / Vendor Oversight: Manages higher-level negotiation and provides oversight of budget, resources and timelines with contract research organizations (CROs) for multiple projects of RWE and ensures timely delivery of high-quality deliverables at reasonable cost.

Global Health Authority Interaction / Negotiation: Reviews documents and responses related to RWE submitted to health authorities. Represents the function at health authority meetings.

Global BDM Strategy to Improve RWE infrastructure and expertise: Leads implementation of vision, strategy, and identifies technology needs for the RWE to improve RWE infrastructure and expertise. Authors or initiates writing of global standard operating procedures for RWE. Oversees compliance of standard procedures and processes.

Group build: Responsibilities for planning group structure, processes, resource planning and management, recruiting/retaining/developing/managing employees.


Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

Ph. D. or MS Degree in Statistics or Biostatistics or equivalent fields

10+ years for Ph D and 13 years for a MS relevant experience in the pharmaceutical industry. People management and RWE experience is preferred.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. 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.