- Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR): Leads statistical activities for very complex studies or an entire project. Act as statistical expert in the assigned projects. Guides the project team in using the most efficient or innovative study design by considering the regulatory agencies' requirements for the country and Regions the compound will be submitted, and helps to maximize the success of the drug product. Serves as project statistician and ensures the study designs are scientifically sound, the efficacy and safety information meets regulatory requirements of the countries and Regions the drugs will be submitted. Ensures consistency in data collection, derived data definition, analysis file structure, statistical analysis and result interpretation throughout the drug project; Leads the planning and analysis of integrated efficacy and safety data; Review the relevant sections of the electronic common technical document (eCTD).
- Drug Development Strategy: Provides input to the entire development plan to ensure the overall strategy can deliver the prespecified product profile, is logical, scientifically sound, proposed studies have appropriate designs, efficacy and safety information to be collected meet regulatory agencies' requirements for countries and regions the drug is to be submitted. Research statistical methodologies and addresses specific statistical issues in the design of clinical studies from preclinical through Phase 3 and 4.
- CRO /
- Global Health Authority Interaction / Negotiation: Authors documents and responses submitted to Health Authorities globally with some guidance from supervisor. Represents statistics function to Health Authorities meetings as needed.
- Global BDO Strategy to
- Master's Degree in statistics or biostatistics required
- PhD in statistics or biostatistics preferred Experience Qualifications
- 10+ Years of relevant experience in the pharmaceutical industry with a masters degree required
- 7+ Years of relevant experience in the pharmaceutical industry with a PhD preferred Travel
-
MSD Malaysia Rahway, United StatesAssociate Director, Medical Operations, Innovation and Emerging Projects page is loaded · Associate Director, Medical Operations, Innovation and Emerging Projects · Apply · remote type · Hybrid · locations · USA - Pennsylvania - North Wales (Upper Gwynedd) · USA - New Jers ...
-
Merck Sharp & Dohme (MSD) Rahway, NJ, United StatesJob DescriptionRole SummaryThe Associate Director, Medical Operations, Innovation and Emerging Projects (AD, IEP) is a role within Global Medical and Value Capabilities (GMVC) in Global Medical and Scientific Affairs (GMSA) that reports directly to the Director, Medical Operation ...
-
Merck & Company, Inc. Rahway, United StatesRole Summary. The Associate Director, Medical Operations, Innovation and Emerging Projects (AD, IEP) is a role within Global Medical and Value Capabilities (GMVC) in Global Medical and Scientific Affairs (GMSA) that reports directly to the Director, Operations, Director, Medical, ...
-
BD (Becton, Dickinson and Company) Franklin Lakes, United StatesJob Description Summary · We are the makers of possible · BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering ...
-
Senior physician
2 weeks ago
FusionTech Manhattan, United StatesThere are many reasons to collaborate with European Medical Consulting Adam in Manhattan. In the following section, you will see how you can benefit from our free services and save valuable time: · You will learn about exclusive and unpublished positions · You will be relieved by ...
-
Sales specialist
2 weeks ago
Omega Innovations Holland, United StatesBrasseler is one of the world's leading manufacturers of precision instruments for dental and human medicine. Our family-owned company was founded in 1923 and is one of the most important employers in the Lippe region with over 1,350 employees. With our brand Komet, we have succe ...
-
Specialist (m/f/d) in Radiology #14568
2 weeks ago
Spectrum Industries York, United StatesThere are many reasons to collaborate with European Medical Consulting Adam. In the following section, you will see how you can benefit from our free services and save valuable time: · You will learn about exclusive and unpublished positions · You will be relieved by our relocati ...
-
Content Creator
2 weeks ago
Spectrum Ventures Manhattan, United StatesWelcome to Klinikum Nürnberg With approximately inpatient and outpatient patients per year, we are one of the largest municipal hospitals in Germany. Our team of 8,400 employees is dedicated to the well-being of our patients. We offer a wide range of medical specialties and are c ...
-
Electronics technician for electrical testing
2 weeks ago
Fusion Dynamics York, United StatesFor almost 50 years, SCHLEIFRING has been synonymous with innovative and highly reliable transmission technologies. Our development and product range includes contacting slip rings, non-contact rotary transmission techniques, and custom system solutions for the medical technology ...
-
Omega Innovations New Holland, United StatesAbout AFRA GmbH: · We see ourselves as a team of dedicated software developers with high quality standards. We place great value on technical and social competence, personal responsibility, and collegial interaction. For our clients, we realize technically demanding and complex s ...
-
NovaTech Solutions North Hudson, United StatesAbout the Company · We are Holtzmann & Son · A family-owned company specializing in plumbing, heating systems, renewable energy, and civil engineering. For 125 years, we have been using the latest technology to make bathrooms more beautiful, homes warmer, energy supply more susta ...
-
Nurse Administrator, Hospital Operations
2 weeks ago
NYU Langone Health New York, United StatesNYU Langone Health is a world-class, patient-centered, integrated academic medical center, known for its excellence in clinical care, research, and education. It comprises more than 200 locations throughout the New York area, including five inpatient locations, a children's hosp ...
-
lpn
1 day ago
Odyssey House New York, NY, United StatesPosition: Licensed Practical Nurse (LPN) at George Rosenfeld Center for Recovery · Company: Odyssey House - Helping New Yorkers beat drugs and alcohol since 1967Our Mission:Odyssey House provides innovative services and programs to individuals and families dealing with substance ...
-
Registered Nurse
6 days ago
ChristianaCare Newark, DE, United States Full timeRegistered Nurse (RN) – 3B General Medical Unit · Night Shift – (Hours: 7p-7a) Weekend & Holidays per department guidelines. · Newark, DE · Christiana Care Hospital in Newark, DE is seeking an experience Registered Nurse (RN) for our 3B General Medical Unit. · Unit · 3B is a ...
-
Medical Director
2 weeks ago
CSG Talent New York, United StatesOur client is a leading Contract Research Organisation (CRO) based out of New York looking for an experienced Oncology Medical Director to join their diverse and growing team to lead new initiatives and provide strategic leadership. This role will work closely with the commercial ...
-
Registered Nurse
1 week ago
ChristianaCare Newark, DE, United States Full timeRegistered Nurse (RN) - 3B General Medical Unit · Night Shift (Hours: 7a-7p) · Newark, DE · Christiana Care Hospital in Newark is seeking a Registered Nurse (RN) for our 3B General Medical Unit. · The scope of services on 3B Medical encompasses a variety of diagnoses including ...
-
Hackensack Meridian Health New Jersey, United StatesRegional Medical Director Oncology · Regional Director of Surgical Oncology · Monmouth and Ocean Counties · Hackensack Meridian Health is seeking an experienced surgical leader to take on the role as Regional Medical Director of Oncology for Jersey Shore University Medical Center ...
-
Digital Client Partner, CMAO
2 weeks ago
Pfizer New York, United States Full timeWhy Patients Need You · Technology impacts everything we do. Pfizer's digital and 'data first' strategy focuses on implementing impactful and innovative technology solutions across all functions from research to manufacturing. Whether you are digitizing drug discovery and develo ...
-
Rn med surg
2 days ago
Capleo Global New York, United StatesCompany Description · Capleo Global is a global business professional services company located in New York, NY. We provide comprehensive services including strategy and consulting, technology innovation, operational excellence, and tailored staff augmentation to companies of all ...
-
Registered Nurse
3 weeks ago
Manhattan Restorative Health Sciences New York, United StatesJob Description · As a REGISTERED NURSE, you will tackle a wide variety of interesting challenges, and uncover key insights that will drive positive outcomes for our patients. · With over 17 clinics across Greater New York City, Manhattan Restorative Health Sciences (MRHS) is New ...
Director of Medical Innovation - New Jersey, United States - Daiichi Sankyo, Inc.
![Daiichi Sankyo, Inc. background](https://contents.bebee.com/companies/us/daiichi-sankyo-inc/background-LLFbm.png)
Description
Join a Legacy of Innovation 110 Years and CountingDaiichi 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 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people.
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.
SummaryPosition leads very complex studies or entire drug project in study design, data analysis and interpretation of results independently with minimal supervision.
This position provides input to entire drug development plans with minimal supervision and authors regulatory responses and other documents with minimal supervision.
This position interacts with global project teams and global Health Authorities, as well as contract research organization (CRO) programmers and statisticians.
Additionally, this position works under minimal supervision to solve complex project problems.Responsibilities
Vendor Oversight:
Participates in drafting request for proposal for CRO selection.
Reviews and negotiates baseline budget and timelines; Guides CRO biostatistician and statistical programmers on assigned projects to ensure consistency in derived data definition, analysis files structure, analysis methodologies, and accuracy of analysis results.
Ensures timely delivery of high quality deliverables.Improve Drug Development:
Leads global BDO initiatives to improve the harmonization and efficiency of drug development which leads to cost savings with minimal supervision
Qualifications:
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education /Qualifications (from an accredited college or university)
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.