Responsibilities: SAS Programming: You'll utilize advanced SAS programming skills to analyse and report clinical trial data (both safety and efficacy). CDISC Standards: Proficiency in CDISC standards (SDTM & ADaM) is essential. You'll ge...
Responsibilities: Provide hands-on Statistical Programming expertise for client's early phase translation medicine group. Responsible for creating ADaM safety datasets such as ADSL, ADLB, ADVS, ADEX, ADPC (concentration), ADPP (parameter...
Responsibilities: Review and apply data mappings for customer specific data exports. Perform peer review / QC of data export programming. Produce data transfers via data export files and/or web services. Work with customers to speci...
Responsibilities: Provide hands-on Statistical Programming expertise for client's early phase translation medicine group. Responsible for creating Adam safety datasets such as ADSL, ADLB, ADVS, ADEX, ADPC (concentration), ADPP (parameter...
Responsibilities: Looking for an experienced senior lawyer with current corporate in-house experience. Has experience working in a pharmaceutical corporate environment. Has good experience with regulatory, distribution, supply, commerci...
Responsibilities: The Regulatory Affairs Specialist coordinates, facilitates, and reports on post-market regulatory programs. Support the IA business units in meeting global registration requirements. As a regulatory process expert sup...
Responsibilities: Perform data entry using Gilead Information Systems to enter and maintain relevant product information to support cross-functional stakeholders. Work collaboratively to support the RA CMC team to meet deliverables and t...
Responsibilities: Build SAS datasets from clinical database. Supporting CDM (Clinical data Managers). Experience in R and SAS Programms. Experience in Spot fire. Program electronic edit checks and data listings required for data revie...
Responsibilities: Perform case processing activities (triage, data entry, report distribution) as required. Assess, process, and data enter all AE case types to meet compliance requirements. Perform triage on all case types to determine...
Responsibilities: The Senior Study Data Tabulation Model (SDTM) Statistical Programmer provides oversight and creation of the SDTM deliverables for analysis and reporting and world-wide regulatory application submissions of drug and vacci...
Responsibilities and Requirements: Our client is looking for a senior level Quality Engineer specialist with significant DHF remediation knowledge. The client has deliverables coming up and needs a consultant to help hit specific deadlin...
Responsibilities: Develop global or US regulatory strategy for Oncology products in development and through life cycle management, considering all relevant guidance, commercial needs, and company objectives. Develop strategic direction a...
Responsibilities: The Regulatory Affairs Specialist coordinates, facilitates, and reports on post-market regulatory programs. Support the IA business units in meeting global registration requirements. As a regulatory process expert suppo...
Responsibilities and Requirements: Develop and maintain SAS programs to import, clean, and validate clinical trial data. Use R for data manipulation, analysis, and visualization. Perform statistical analyses in accordance with study p...
Responsibilities: Create documentation for regulatory filings including reviewers guides and data definition documents Participate in the development of standard SAS Macros. Develop SAS programs for the creation of ADaM data sets follow...
Responsibilities: The Regulatory Affairs Specialist II will support the IA business unit in meeting global registration requirements. As a regulatory process expert supporting global registrations the candidate interprets federal/state/i...
Responsibilities: Act as primary liaison between Company and CRO for Data Management. Provide support and oversight for the CRO Data Management team. Collaborate with the team on study design, protocol development, CRF design, statistic...
Responsibilities: Creation of SAS programs to Develop or Validate SDTM/ADaM/TLFs. Provide oversight for CRO SDTM/ADaM/TLFs deliverables for multiple studies and make sure efficiencies are gained at project level. Generate and/or review ...
Responsibilities and Requirements: Configure retirement services products and features within the technology platform to meet business requirements and regulatory standards. Collaborate with stakeholders to define product specifications ...
Responsibilities: Provide QA support on the floor for production. Ensure process control measures are in place and followed in product manufacturing. Receipt and disposition of incoming apheresis material. Oversee and authorize shipmen...