Latest Jobs at Synteract

Position Overview

• The Clinical Database Builder is responsible for Case Report Form (CRF) development and clinical study database build in accordance with the Clinical Data Management System (CDMS) guidelines and Synteract standards for CRF development and study build. You'll ensures on-time delivery and communicates the status of projects to internal teams.

Specific Tasks Would Include

• Performs, or assists with, the validation of clinical study databases.
• Provides support for user account administration for all in-house Clinical Data Management Systems (CDMS), including Medidata Rave or Marvin.
• Implements and QC‘s efficient Electronic Data Capture (EDC) clinical databases; building forms (using Adobe Framemaker if a paper project or the CDMS) and fields per specifications provided by Data Managers.

Qualifications

• Bachelor’s degree in a relevant field of study and 0-2 years related work experience inclusive of or equivalent combination of education, certification and experience.
• Fundamental understanding of data management practices and clinical data management systems (CDMS).
• Fundamental understanding of Clinical Trial processes, specifically as they are related to data collection and management.
• Fundamental understanding of data capture / data reporting and industry standards such as SDTM and CDASH.
• Fundamental understanding of 21CFR11, HIPAA and computerized systems validation.
• Proficiency in Microsoft Office; Word, Excel, PowerPoint, Outlook as required.
• Basic proficiency in graphic programs such as Adobe Framemaker and Adobe Acrobat.
• Effective verbal and writing skills; English + local language, if relevant.



 

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Position Overview

• The Biostatistician plans and conducts the summaries and analyses of data for assigned clinical studies. Works closely with the Sponsor, clinical team, project manager, data manager, other Biostatisticians, and programmers to analyze and present the data based on Sponsor specifications. Creates, verifies/validates, maintains, and reviews the statistical analysis code and the tables, listings, figures, and analysis outputs for assigned studies in compliance with standard operating procedures and relevant regulatory guidances.

Specific Tasks Would Include

• Maintain responsibility for assigned tasks: ensure on-time delivery, communicate the status of tasks to internal teams, provide quality control of work produced by others, and ensure statistical analysis is being done according to specifications.
• Read and understand the protocol, statistical analysis plan, and other relevant study documentation for assigned studies.
• Provide sample size calculations and documentation for simple studies.
• Generate randomization schedules and kit lists.
• Review case report forms for assigned studies to ensure data is collected appropriately to achieve the analysis defined in the protocol.
• Contribute to statistical analysis plans and produce mock table and listing shells.
• Review specifications for derived data sets.
• Create programming code for inferential analyses, and ensure programming is being done according to Synteract SOPs and Sponsor expectations.
• Review tables, listings, figures, and analysis output.
• Perform bibliography research for statistical analysis techniques
• Maintain responsibility for assigned studies: ensure on-time delivery, communicate the status of studies to internal teams and Sponsors, provide quality control of work produced by others, and ensure statistical analysis is being done according to specifications.
• Review the protocol, statistical analysis plan, and other relevant study documentation for assigned studies and provide feedback.
• Provide sample size calculations and documentation for more complex studies.
• Serve as lead statistician for assigned studies, and coordinate and monitor work assignments of other supporting Biostatisticians.
• Write statistical analysis plans and produce mock table and listing shells.
• Work closely with internal teams and Sponsors to ensure high quality, timely deliveries of tables, listings, figures, statistical analyses, and reports.
• Write statistical reports to summarize study results.
• Review statistical results sections of clinical study reports.
• Represent Biostatistics in communication with internal teams and Sponsors Contribute to the protocol for assigned studies by adding to the statistical methods section and providing input on study design issues, endpoint definitions, and sample sizes.
• Serve as lead statistician for programs of studies and ensure consistency across multiple studies for a single Sponsor.
• Provide a senior review of statistical analysis plans and mock table and listing shells for other Biostatisticians.
• Provide a senior review of tables, figures, listings, and analyses for other Biostatisticians.
• Serve as Independent Reporting Statistician for Data Monitoring Committees.
• Provide statistical guidance and training for other Synteract Biostatisticians.
• Participate in on-study and post-study audits.
• Contribute to the business development process by participating in bid defences.

Degree And Experience

• Master's degree or equivalent in statistics, mathematics or related field of study and a minimum of 5 years related experience or equivalent combination of education and experience.

Specific Knowledge

• Possesses an intermediate understanding of a wide range of statistical methods relevant to clinical trials.
• Understands the design, randomization, sample size calculation, conduct, analysis, and reporting of clinical trials.
• Understands data management, programming, medical writing, and regulatory issues associated with clinical trials.

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Position Overview

• The SAS Programmer is responsible for executing programming activities in coordination with project teams with supervision. S/he will develop, create, verify/validate and maintain managing the programs for assigned projects in compliance with standard operating procedures.

Specific Tasks Would Include

• Participates in the validation of SAS programs and maintaining validation documentation.
• Familiarizes oneself with the SAS dataset structure and format catalog related to a given study.
• Familiarizes oneself with the documents associated with a given study.Such documents include (but are not limited to) edit check documents, SAS and database annotated Case Report Forms (CRFs), visit map/schedule of events, CRFs, code lists, statistical analysis plan (SAP), data management plan (DMP), clinical protocol, programming-specific documentation.
• Develops, programs and maintains:
  • SAS edit checks and SAS edit check listings.
  • Subject profile programming used for quality control of paper-based project databases.
  • Data line listings as requested by the Sponsor and/or internal project teams.
  • Clean subject programming used to identify clean subjects for a given project.
  • JReview objects and registry of SAS datasets.
  • SAS programs used to generate random samples of subject numbers and calculate database reliability rate during the quality control of paper-based project databases.
  • Study Data Tabulation Model (SDTM) dataset programming.
  • Programs that download external data received from various data sources.
  • External data reconciliation programs.
  • Programs that generate CRF and Query metrics.
  • Ad-hoc Sponsor and internal programming requests.

Qualifications

• Bachelor’s degree in a relevant field of study and 0-2 years data management or SAS programming experience or equivalent combination of education and experience.
• Possess an underlying understanding of data management practices and clinical data management systems (CDMS).
• Possess a basic understanding of the Clinical Data Interchange Standards Consortium (CDISC) domain and item names and the role of CDISC in drug development.
• Understands the sequence of running programs to ensure up-to-date data and to troubleshoot, debug programming problems and to identify data trends.
• Proficiency in Microsoft Office; Word, Excel, PowerPoint, Outlook as required.
• Effective verbal and writing skills; English + local language, if relevant.