Smith Hanley Consulting Group - Raleigh, NC
Collaborate with research teams in conducting Health Outcomes studies utilizing large national/international cross-sectional and longitudinal healthcare databases. Provide statistical programming, database management and systems analysis support and consultation for health outcom...
Smith Hanley Consulting Group - Princeton, NJ
Primary responsibilities will be Validation of the Data Analysis for CSRs, ISS, Annual reports , etc. Consultant will be providing validation for OPC14597 IMDepot studies. Sr. SAS Validation Programmer Required Qualifications: MS (preferred) or BS with 5 years of SAS Programmin...
Smith Hanley Consulting Group - Bedminster, NJ
The person will be joining an established team responsible for creating an analysis data set based on a clinical database. The person will be responsible for developing tables, graphs and listings and will, in turn, provide statisticians the information. The statisticians will g...
Sr. Regulatory Compliance Auditor
Smith Hanley Consulting Group - Menlo Park, CA
Audits areas of the company Vascular quality system, such as development and manufacturing, as assigned Creates audit checklists based on assigned area, applicable regulations, and pertinent company Vascular quality system/procedural requirements, and obtains approval from Lead A...
Smith Hanley Consulting Group - Bridgewater, NJ
Comprehensive knowledge of clinical and pharmaceutical drug development process and associated Good Clinical Practice (GCP). Awareness of regulatory requirements e.g. Food and Drug Administration (FDA) and International Conference on Harmonization (ICH) guidelines. Multi-phase ex...
SAS Developer – Development Lead
Smith Hanley Consulting Group - Lawrenceville, NJ
As a member of the Clinical Pharmacology and Pharmacometrics (CPP) group in the department of Discovery Medicine and Clinical Pharmacology, you will use the SAS programming language in a Windows/UNIX environment to: Prepare analysis data sets, tables, listings and figures Load da...
Smith Hanley Consulting Group - Franklin, OH
Technical Writing role writes, or supports the development of, various technical documents such as: requirements, specifications, test plans, and user manuals. Provides evidence of compliance with legal, business and regulatory requirements; Translates highly technical software f...
Medical Communications Professional- Thrombosis
Smith Hanley Consulting Group - Edison, NJ
Write and conduct medical review of scientifically sound and fair-balanced responses to unsolicited inquiries and requests for information (which includes conducting thorough literature searches across multiple databases and providing expert analysis of the relevant data). Fulfil...
Clinical Operations/Clinical Supplies Manager
Smith Hanley Consulting Group - Titusville, NJ
Has strong internal collaborations and relationships with the TAs and GCO to ensure customer satisfaction. This individual contributor is responsible for design and demand management of clinical supplies aligned per Therapeutic Area. Develops supply strategies matching needs of c...
Clinical Study Leader/Medical Director, Clinical Development
Smith Hanley Consulting Group - Edison, NJ
The Medical Director- Clinical Development is a critical role within Clients Clinical Development group for implementation of clinical development plans for the assigned global and regional compound development projects. This position provides rigorous clinical and scientific lea...
Smith Hanley Consulting Group - Woodcliff Lake, NJ
Under minimal supervision, perform all data management functions to ensure timely and quality database lock for studies Phase I-III. Perform data management activities for EDC studies conducted in-house as well as oversee activities of off-shore CRO handling outsourced projects (...
Smith Hanley Consulting Group - Edison, NJ
Provide SAS program support to multiple-trial programs, complex clinical trials, and submission projects (including Integrated Summary of Safety or Efficacy). Assist in the production of derived dataset specifications, programming specifications. Use efficient programming techniq...
Smith Hanley Consulting Group - East Hanover, NJ
To Lead and Manage project activities at Study level at assigned client sites for Clinical Data Management and ensure efficient coordination among Study Teams and Data Management Teams. Key Accountabilities: Act as a single point of contact for all data management center delivera...
Smith Hanley Consulting Group - Edison, NJ
7 – 10 years Pharma Experience as a Biostatistician, Statistical Programmer, or SAS Programmer...
Medical Communications Professional- Thrombosis
Smith Hanley Consulting Group - Edison, NJ
Write and conduct medical review of scientifically sound and fair-balanced responses to unsolicited inquiries and requests for information (which includes conducting thorough literature searches across multiple databases and providing expert analysis of the relevant data). Fulfil...
Smith Hanley Consulting Group - Woodcliff Lake, NJ
Perform SAS programming to provide complex listings/reports to support Data Management function for clinical data review for Oncology trials. Provide patient profiles and ad-hoc reports for data review to support the clinical teams. Assist in preparing datasets for statistical ...