Director, Biostatistics - RWE

Location
Basking Ridge, NJ, United States
Posted
Nov 16, 2020
Ref
10526BR
Hotbed
Pharm Country
Required Education
Masters Degree/MBA
Position Type
Full time
Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Summary:

This position serves as the Biostatistical expert supporting projects and activities of real world evidence (RWE). The incumbent will be responsible for providing statistical technical support and strategy for all RWE activities. The position is accountable for the statistical strategy and deliverables to support RWE activities in timely fashion with adequate quality. The position is also responsible for implementing innovations and maintaining operational excellence for RWE.

Responsibilities:

Statistical deliverables and analyses: Performs statistical analyses in supporting RWE projects. Performs 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: Provides statistical expertise and skills to support formulating RWE strategy as the subject matter expert in statistics. Supports streamlined and consistent global RWE strategies throughout research, development, and post-marketing.

CRO / Vendor Oversight: Manages and provides oversight of performance, productivity, 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: Supports documents and responses preparation related to RWE submitted to health authorities. Represents the function at health authority meetings.

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

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

Sufficient oral and written communication skills

Strong expertise in drug development including statistical knowledge and skills in trial study designs, statistical analyses, data interpretation, Big data and machine learning, and RWD

Project planning resource management skills

Demonstrated strong execution/implementation capability, strategic thinking and excellent collaboration skills

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.
Job Title
Director, Biostatistics - RWE

City
Basking Ridge

Functional Area
Biostatistics & Data Management

State
New Jersey