- Direct activities of assigned group(s) to ensure effective performance of function.
- Serve as a model to departmental subordinates as it relates to effective time management, communication, and utilization of resources.
- Provide leadership and motivation to departmental personnel.
- Interact collaboratively and cooperatively with other departmental and company staff to ensure that project and department activities are successfully completed.
- Establish, maintain, and strengthen a professional working relationship with clients, potential clients, regulatory agencies, collaborating staff, vendor, and subcontract personnel.
- Actively monitor project budgets and help staff identify resourcing or scope of work changes.
- Provide accurate and timely status updates to other team members, colleagues, and senior management.
- Successfully represent department and company in a multi-disciplinary setting, such as project teams, project meetings, and client meetings/presentations.
- Advocate the departmental team approach for effective management of broad based projects such as NDA submissions or complex, multi-protocol programs potentially coordinating activities across multiple locations.
- Assist in the development of short- and long- range operating objectives, budget, organizational structure, and staffing requirements. Assist in the development of a departmental plan for backup and succession of key departmental personnel.
- Assist in the development, maintenance, and communication of departmental systems and SOPs.
- Monitor and provide daily supervision and review work of assigned departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures.
- Identify training and development needs of direct reports. Assist in the development, implementation, and delivery of departmental training programs; ensure that direct reports receive departmental orientation and necessary on-the-job training.
- Serve as primary statistical oversight for Biostatistics standalone or otherwise complex studies.
- Develop and review statistical analysis plans based on study specific documents and sound statistical methodology.
- Develop, maintain, and produce statistical programs and specifications used in creating analysis datasets, tables, listings, and figures.
- Education: Master's degree (M.A., M.S.) or equivalent in Biostatistics or related field.
- Experience: 8+ years related clinical research experience
- 5+ years successfully leading statistical activities in clinical research.
- 5+ years supervisory experience required.
- Previous CRO experience required
- Other: Knowledge of the drug development process and FDA and ICH Guidelines required. Experience with regulatory submissions is preferred.
-
Biostatistics Director
5 days ago
Amgen Washington, United States**HOW MIGHT YOU DEFY IMAGINATION?** · If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborator ...
-
Biostatistics Director
4 days ago
Amgen Washington, United States**HOW MIGHT YOU DEFY IMAGINATION?** · If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborator ...
-
Biostatistics Associate Director
5 days ago
Amgen Washington, United States**HOW MIGHT YOU DEFY IMAGINATION?** · If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborator ...
-
Senior Director, Biostatistics
5 days ago
Amgen Washington, United States**HOW MIGHT YOU DEFY IMAGINATION?** · If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborator ...
-
Senior Director, Biostatistics
4 days ago
Amgen Washington, United States**HOW MIGHT YOU DEFY IMAGINATION?** · If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborator ...
-
Associate Director, Biostatistics
4 days ago
Vanda Pharmaceuticals Washington, United StatesPrimary Responsibilities · Working as leading statistician on multiple studies/projects across different therapeutic areas. Contribute to clinical trial design, protocol development and Clinical Study Report (CSR) · Participate study related activities and provide statistical co ...
-
Associate Director, Biostatistics
1 week ago
Vanda Pharmaceuticals Washington, United StatesPrimary Responsibilities Working as leading statistician on multiple studies/projects across different therapeutic areas. Contribute to clinical trial design, protocol development and Clinical Study Report (CSR) · Participate study related activities and provide statistical cons ...
-
Duke Psychiatry Clinical Research Unit
1 week ago
InsideHigherEd North Carolina, United States Faculty Jobs , Administrative Jobs ,The CRU Director has overall responsibility for ensuring the integrity, financial accountability, regulatory compliance, quality, and academic productivity of clinical and translational human subjects' research taking place within their unit. This is an assistant professor positi ...
-
Associate Medical Director/Medical Director
3 weeks ago
Thermo Fisher Scientific North Carolina, United States Full timeOverview: Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators ...
-
Sanofi Group West Columbia, United StatesSanofi Group · Associate Director, Medical Value and Outcomes, East Region · Columbia , · South Carolina · Apply Now · The Medical Value & Outcomes (MVO) team member (Senior Manager, Associate Director or Director) serves as the medical scientific lead for population-based h ...
-
Director, Statistical Innovation
5 days ago
Amgen Washington, United States**HOW MIGHT YOU DEFY IMAGINATION?** · If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborator ...
-
Clinical Research Medical Director
5 days ago
Amgen Washington, United States**HOW MIGHT YOU DEFY IMAGINATION?**If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborato ...
-
Program Officer, Workforce Development
2 weeks ago
PCORI Washington, United States· Program Officer, Workforce Development (Healthcare Research) · LinkedIn · Twitter · Email · Message · Share · Post Date · 4/22/2024 · Job Location · 1333 New Hampshire Avenue, NW, Washington, District of Columbia · Department: Workforce Development, PCOR Infrastructure and Inn ...
-
Program Officer, Implementation Science
2 weeks ago
Staffing Advisors Washington, United StatesOverview · Program Officer, Implementation Science · As a Program Officer, Implementation Science at the Patient-Centered Outcomes Research Institute (PCORI), you will be responsible for high-level program planning and management, oversight of an award portfolio, and leadership ...
-
Senior Program Officer, Implementation Science
2 weeks ago
PCORI Washington, United States· Senior Program Officer, Implementation Science · LinkedIn · Twitter · Email · Message · Share · Post Date · 4/5/2024 · Job Location · 1333 New Hampshire Avenue, NW, Washington, District of Columbia · Division: Comparative Clinical Effectiveness Research (CER) · Reports to: Ass ...
-
Program Officer, Workforce Development
1 week ago
PCORI Washington, United StatesProgram Officer, Workforce Development (Healthcare Research) · Post Date · 11/29/2023 · Job Location · 1333 New Hampshire Avenue, NW, Washington, District of Columbia · Department: · Workforce Development, PCOR Infrastructure and Innovation · Reports to: · Associate Directo ...
-
Program Officer, Implementation Science
2 weeks ago
Staffing Advisors Washington, United StatesOverview · Program Officer, Implementation Science · As a Program Officer, Implementation Science at the Patient-Centered Outcomes Research Institute (PCORI), you will be responsible for high-level program planning and management, oversight of an award portfolio, and leadership ...
-
Program Officer, Implementation Science
3 weeks ago
Staffing Advisors of Maryland Washington, United StatesOverview · Program Officer, Implementation Science · As a Program Officer, Implementation Science at the Patient-Centered Outcomes Research Institute (PCORI), you will be responsible for high-level program planning and management, oversight of an award portfolio, and leadership o ...
-
Data Manager
1 week ago
Penn Foster Inc Washington, United States Full timeLocated in a historic neighborhood in the nation's capital, Georgetown offers rigorous academic programs, a global perspective, exciting ways to take advantage of Washington, D.C., and a commitment to social justice. Our community is a tight knit group of remarkable individuals i ...
-
Program Officer, Strategy
4 days ago
PCORI Washington, United States· Program Officer, Strategy · LinkedIn · Twitter · Email · Message · Share · Post Date · 4/16/2024 · Job Location · 1333 New Hampshire Avenue, NW, Washington, District of Columbia · About Us · The Patient-Centered Outcomes Research Institute (PCORI) is an independent nonprofi ...
Associate Director, Biostatistics - North Carolina, United States - PharPoint Research, Inc.
Description
Summary
In this position, you will provide overall technical, administrative and functional oversight for the Biostatistics functions of the organization which include statistical consulting, statistical analysis plans, protocols, study reports, and other statistical sections of NDAs and other drug, device, or biologic regulatory submissions. Oversee the efficient, accurate, and timely execution of all assigned Biostatistics projects within the division.
What you will do
Qualifications
