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Regulatory and Start Up Specialist

Job Overview:

• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
• Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Perform admissions of regulatory documents.
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Perform quality control of documents provided by sites.
• Inform team members of completion of regulatory and contractual documents for individual sites.

Requirements:

• Bachelor’s Degree in life sciences or a related field
• 3 years clinical research experience, including 1 year experience in a leadership capacity or equivalent combination of education, training, and experience.
• In-depth knowledge of clinical systems, procedures, and corporate standards.
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
• Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards.
• Understanding of regulated clinical trial environment and knowledge of drug development process

Senior / Principal Statistical Programmer

Job duties:

• Development of study outputs including SDTM/ADaM datasets, tables, listings, figures and QC of requested output.
• Participate in the design, development and quality control process for SAS programs used to access, extract, transform, review, analyze and submit clinical data for all requested analyses.
• Interact with internal departments of the sponsor – Biostatistics, Data Management, Regulatory Operations and Medical Writing.
• Collaborates with peers and statisticians to ensure the submission readiness of clinical data as required by authorities (i.e. SDTM, ADaM, tables, figures, listings, define.xml).
• Involvement with creation and maintaining programming specifications for SDTM, ADaM and integration of data in support of ISS/ISE.
• Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group.
• Perform additional statistical analyses including but not limited to: support responses to regulatory agencies; generate integrated summary of safety and efficacy; support publications and presentations; support planning and reporting of clinical trials via exploratory analyses of available data; replicate vendor and statistician analyses for QC.

Our expectations of you:

• 5 years or more in SAS programming for clinical trial data.
• Bachelor’s degree in Math, Stats, Computer Science, Pharmacy, Biology or related.
• Strong knowledge in CDISC standards (SDTM, ADaM).
• Knowledge in the creation of define.xml, Pinnacle 21, aDRG, and sDRG.
• Knowledge of pharmaceutical clinical development – understanding of safety deliverables and efficacy analysis supporting regulatory submissions.
• Knowledge of base SAS, proc report, exposure to macros, current CDISC data structures, and standardization methodology; demonstrated ability to debug SAS programs.
• High degree of technical competence in SAS Macro programming, SAS SQL, XML, RTF, and PDF.
• Demonstrated teamwork, pride of ownership, accountability, problem-solving and innovative skills.

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