- Education: N/A
- Functional Area: Pharma / Biotech / Healthcare / Medical / R&D
- Industry: Medical/Healthcare/Hospital
Local candidate to Minneapolis strongly preferred but manager is open to remote candidates as well.
To participate in the planning, design, and implementation of clinical trial protocols using sound statistical methodology. To evaluate clinical studies in terms of safety, efficacy, and marketability through statistical analysis. To participate in the documentation of study results in clinical reports for various regulatory submissions. To participate in the preparation of abstracts, oral and poster presentations, and publications relating to the study results. Works under general direction.
MAIN JOB DUTIES/RESPONSIBILITIES
1. Work with cross-functional teams to develop and refine study objectives to establish the safety and efficacy of medical device therapies and diagnostics.
2. Participate in development and documentation of study protocols with responsibility for scientific soundness sections, which include statistical hypotheses, sample size calculations, and analysis methods for meeting the study objectives, in collaboration with others.
3. Perform analyses of study data including documentation and justification of the statistical methods, analyses, and results in clinical reports, abstracts, and manuscripts.
4. Interact with FDA reviewers, especially statistical, to negotiate appropriate study designs, to explain the quantitative results of clinical studies, and to defend the analytical approach.
5. Remain current on state-of-the-art statistical methods useful in clinical trial design and analysis.
6. Contribute to the development of policies and procedures for the department and the statistics group.
7. Develop statistical programs (e.g., using SAS, S-PLUS, R, WinBUGS) for data extraction, statistical analysis, and report generation.
8. Perform statistical program validation in accordance with departmental Standard Operating Procedures.
9. Identify potential threats to study credibility and validity, and work with study teams to prevent, track, and manage potential problems.
10. Write statistical analysis plans.
11. Participate in the design of case report forms and ensure consistency between the data collected and the objectives of the study.
12. Work with the information systems staff and the clinical study team to develop specifications for the database design that assure the quality, integrity, and timely availability of the data for monitoring and analysis purposes.
13. Participate in investigator meetings.
14. Manage multiple, varying sized projects concurrently.
(What is absolutely required to do this job) PREFERENCES
(Things that make it easier to do this job)
KNOWLEDGE/EDUCATION AND JOB EXPERIENCE
• M.S. in Statistics, Biostatistics, or related field with 4-7 years of experience working with clinical study data.
• Proficient statistical programming skills.
• Good oral and written communication skills.
• Ph.D. in Statistics or Biostatistics.
• Proficient in SAS.
• Knowledge of clinical trial methods and execution in a regulated environment.
• Experience applying Bayesian methods to clinical trials.
• Experience in medical device, biotechnology, or pharmaceutical industries.
• High level of competency in Windows environment and with Microsoft Office Tools (Word, Excel).
• Strong interpersonal, customer-focused and collaborative skills.
• Ability to manage multiple projects concurrently.
Select Source International is a Global Solutions provider of IT staffing and Project services. Our service offering has 5 main practices; ERP, Application Development, Middleware, Database Management and Project Services. SSI offers industry leading Data Migration, Compliance, and Risk Management through its subsidiary Data Wave. Data Wave offers Cyber Security and risk management through a GRC product suite called Risk Utilities. In addition to our technology offerings, SSI also provides administrative and business consulting services. Industry Experience: Retail Healthcare Manufacturing Energy and Utilities Government Financial Engineering.
- Name: Mukesh Sharma
- Email: firstname.lastname@example.org
- Phone: 9525463300
- Extension: 6003
- Name: Select Source International
- Website: www.selectsourceintl.com