- Compile and review SDTM and ADaM dataset specifications, annotated patient Case Report Forms (aCRF) and other related programming documentation (e.g., files, tables, charts, reviewers' guides for SDTM and ADaM datasets) for integration in reports based on Everest company standard operating procedures (SOPs) and Working Instructions (WIs), which are compliant to the pharmaceutical clinical research industry standards, conventions, and regulatory requirements and meet clinical trial Sponsorspecific requirements.
- Process SDTM and ADaM datasets following authorized dataset specifications, these may include datasets for Clinical Study Reports (CSRs), clinical trial efficacy and safety data integrations (ISS and ISE), as well as other data analysis and reporting needs such as ad hoc and exploratory data analyses.
- Process and validate data and statistical output reports of trial data based on statistical analysis plans and statistical TLGs mockup shells through developing SAS programming codes.
- Conduct basic analysis of trends in clinical trial data through developing SAS programming codes for database logical checks and reports for ongoing data review.
- Collect and consolidate data and programming information from various sources in accordance with Everest company SOPs and WIs to prepare reports to achieve audit readiness during and at the end of the clinical trials for internal and external quality and compliance audits.
- Achieve a high rating for each of the defined Everest company and trial Sponsorspecific statistical programming Key Performance Indicators (KPIs).
- Collect, track and archive clinical trial data (SDTM and ADaM datasets) and programming information in accordance with Everest company archival SOPs and Working Instructions.
- Maintain current knowledge of pharmaceutical clinical research industry standards, conventions, and regulatory requirements, as well as the knowledge of clinical trial Sponsorspecific requirements when applicable.
- Comply to Everest companyspecific and clinical trial Sponsorspecific training requirements.
- Develop and provide expertise in other programming and system administration areas when required.
- May lead statistical research efforts for assigned projects.
- May participate in the development and maintenance of clinical trial data and statistical reporting standards to ensure that the company standards are up to date and in line with pharmaceutical industry standards, conventions, and regulatory requirements.
- Provide technical guidance and support to less experienced Statistical Programmers in the study teams.
- May make decisions on time allocation to complete assigned projects.
- May make decisions on therapeutic area programming standards/conventions/procedures within assigned therapeutic areas as a lead programmer.
- May make decisions on client specific programming standards/conventions/procedures for assigned clients when required.
- May make decisions related to setting project priorities, resource availability, negotiation of project timelines, on therapeutic area and clientspecific programming standards/conventions/procedures, and on clientspecific programming.
- Master's degree in statistics, biostatistics, epidemiology, bioinformatics, mathematic, or computer sciences
- 13 years of experience in clinical trial statistical programming and/or data analysis
- Advanced level proficiency in SAS.
- Demonstrated strong capabilities and/or sustained high level of performance as a Statistical Programmer
- Experience with the following is required:
- Microsoft Word, Excel, PowerPoint, Outlook, Project.
- Experience with statistical software is preferred
- Must be action oriented, have composure, be creative, be customer focused, have functional and technical skills, able to learn on the fly, able to persevere, excellent planning, organizational, time management and problem solving skills, able to prioritize, and able to pick up on new technical skills quickly.
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Statistical Programmer - Markham, Canada - Everest Clinical Research
Description
Employer:
Everest Clinical Research
Position:
Statistical Programmer
Vacancies:
Two (2)
Terms of Employment:
Full-time / Permanent
Location:
Markham, Ontario
Employment Address: 675 Cochrane Drive, East Tower, 4th Floor, Markham Ontario, L3R 0B8 and remote work permitted from home within the Greater Toronto Area.
Language:
English
Benefits:
Eligible for discretionary bonuses and/or salary increases in accordance with company policy. Eligible for medical, dental, vision, extended health benefits, pension, fitness subsidy, life insurance, as well as paid vacation, sick days, and floater days
Salary:
$63,453 - $68,500 CAD per annum
Contact:
Please send resumes to and include "Statistical Programmer" in the email subject line.
Duties:
Requirements:
We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.
