Why Work at SCiAN

  1. Proven experience and a long history in Clinical Research (Pharma & Biotech)
    SCiAN started as a consulting company in 1986. Now, 33 years later (and counting), we offer services in Clinical Data Management, Biostatistics, Pharmacovigilance and custom-database solutions. We have seen the changes in the biotechnology and pharmaceutical landscape and we adapt our services and practices to those changes. We continue to grow and are looking for colleagues who want to be part of our growth!
  2. In-depth training in your position and cross-training across different roles
    If you want to work for a company that will train and expose you to all aspects of a clinical trial, consider SCiAN.
    At SCiAN we believe the more knowledge you have in clinical research, the better you can perform your job. We do not work in isolation. We work as a team. And we firmly believe if the team understands each other's responsibilities and functions, we have a common sense of purpose and most importantly we deliver better results for our clients.
  3. New graduates and seasoned professionals are valued
    At SCiAN our people are our strength and key to our success. We welcome new graduates for their enthusiasm, fresh views and perspectives. We appreciate seasoned professionals for the expertise they bring and the mentoring they will give to new graduates. We believe in a culture of collaboration, respect and empowerment where ideas can be brought to light.
  4. Develop and realise your potential
    We understand that everyone has goals and career aspirations. At SCiAN we encourage you to speak to your manager or senior management about where you want to go. Doors are always open for discussion. We offer significant career opportunities and a path to reach your target in your professional development.
  5. Work/Life Balance
    People who work at SCiAN actually like each other. We encourage a friendly working environment where everyone is supportive of each other. For colleagues who sometimes find the commute laborious, we offer flex time; and the option to work partially from home for experienced staff.

If you have a strong technical and academic background, leadership and collaborative skills, and an interest in clinical research, we invite you to explore our career opportunities.  We are an equal opportunity employer and support diversity in our workplace.

To apply for a position listed below, please e-mail your cover letter and resume to: humanresources@scian.com

 

Position/Title: Principal Biostatistician
Location: Head Office
Status: Full Time
Reports to: Director, Biostatistics and CDM
Subordinates: None
Number of Available Positions: 1

Summary

The successful candidate acts as the lead or back-up project manager for multiple projects and is the primary contact with the sponsor for all Biostatistics and CDM related activities on the projects across major therapeutic areas (oncology, CNS, infectious disease, immunotherapy, stem cell and gene therapies, etc.).

Key Responsibilities

  • Collaborates in protocol development by choosing an appropriate study design, including statistical methodologies, sample size calculation and writing the statistical section of the protocol
  • Writes or reviews Statistical Analysis Plans (SAPs) based on the protocol, including development of mock-up tables, listings and figures.
  • Directs the activities of Biostatistics and CDM personnel on assigned projects to ensure timely completion and high quality of work.  Provides requirements and oversight to the project team and is an independent review of work produced by the project team.
  • Contribute to the review and interpretation of analysis results.
  • Contributes to clinical study reports, including authoring of statistical sections and interpretation of analysis results.
  • Provides support for preparation of publications, including manuscripts, posters and abstracts
  • Conducts and participates in the review and quality control of project deliverables, ensuring that output meets expectations and is consistent with the deliverables defined in the project contract.
  • Conducts time estimates for completion of study related activities with the project team.  Monitors progress on study activities against project milestones and ensures timelines for project deliverables are met.  Manages the project proactively and identifies out-of-scope task and escalates to management.
  • Ensures proper study closeout by documenting and archiving study related materials according to SOPs and/or Sponsor requirements
  • Perform statistical programming, when needed.

Qualifications

  • MSc. or PhD. in Statistics or Biostatistics
  • 5+ years of relevant clinical trial experience
  • Experience in the design, analysis and reporting of clinical trials across a wide range of therapeutic areas including oncology and CNS
  • In-depth knowledge of a range of statistical methodology such mixed models and repeated measures
  • Proven experience with CDISC standards: SDTM and ADaM
  • Knowledge of FDA and ICH regulations and guidelines
  • Proficient in statistical programming (SAS)
  • Team-oriented with proven ability to lead a cross-functional team
  • Willingness to work with others and assist project initiatives as necessary to meet the needs of the project.
  • Strong interpersonal, communication and writing skills.

Position/Title: Statistical Programmer Analyst – Levels 1 - 3

Location: Head Office

Status: Full Time

Reports to: Manager, Biostatistics and CDM

Subordinates: None

Number of Available Positions: 3

Summary

SCiAN's STAT group is responsible for the data analysis and reporting activities associated with IND-stage phase I - III clinical trials.

The successful candidate will contribute to SCiAN's internal STAT project teams and will support the EDC-CDM group to with respect to data management activities.

Key Responsibilities

On a project-by-project basis:

  • Develop and review SAS programs for the reporting of clinical trial data, including analysis-ready datasets (e.g. ADaM, Sponsor-defined), tables, listings and figures (TLFs)
  • Develop specifications and programs for data transfers and assist in their review to ensure the datasets meet the specifications
  • Review draft and production output for projects to ensure quality and consistency
  • Perform QC/statistical review of TLFs for study endpoints
  • Perform statistical analysis of clinical trial data using appropriate methodology, under the supervision of senior statistical staff
  • Assist in the preparation of tables, figure and listing shells under the supervision of senior statistical staff
  • Assist the EDC-CDM group with validation activities (e.g. record reconciliation, off-line data validation checks, etc.), as appropriate
  • Assist in the preparation of statistical reports under the supervision of senior statistical staff
  • Develop problem-solving skills and willingness to learn and seek advice from senior statistical staff
  • Assure quality of personal work.

Qualifications

  • BSc. or MSc. in Statistics (preferred) or related field
  • Experience in statistical programming (SAS preferred) in the Pharma/Biotech industry: Level 1 - 0 to 2 years, Level 2 - 2 to 5 years, Level 3 - 5+ years
  • Knowledge of CDISC, SDTM and ADaM, an asset
  • Knowledge of FDA and ICH regulations and guidelines preferred
  • Effective written and verbal communication skills
  • Cooperative and team-oriented
  • Self-motivated and detailed-oriented
  • Ability to work to tight deadlines while maintaining high standards

Position/Title: Quality Assurance Specialist
Location: Head Office
Status: Contract/Part-time
Reports to: Director, QA
Subordinates: None
Number of Available Positions: 1

Summary

The successful candidate is responsible for administering SCiAN's quality program. S/he works with Operations and Management to ensure the effectiveness and compliance of the quality system.

Key Responsibilities

  • Design and implement ongoing improvements to the quality system working with Management and Operations.
  • Report on the quality system to management.
  • Administer annual training activities (SOP Training, GCP training), maintain the training library and deliver QS training to staff.
  • Oversee review, development and control of SOPs, forms and other QS procedure documents.
  • Involved in the development and/or writing of SOPs, policies and other QS documents.
  • Maintain quality system records including those generated through audit, SOP management, validation, training, deviation & CAPA.
  • Administer the supplier initial and renewal qualification process.
  • Host external audits.
  • Conduct internal audits to assure ongoing compliance with applicable SOPs, regulations and GCP.
  • Report and follow up on audit activities.
  • Act as QA resource for validation of proprietary systems, author or review validation documentation.
  • Maintain system release list and validation document catalogue.


Other Duties

    As assigned.

 

Qualifications

    • Bachelor’s degree in relevant scientific field or Information Technology with at least 2 years QA experience.
    • Demonstrated knowledge and understanding of quality systems (e.g. ISO 9001:2015), document control, and document management.
    • Demonstrated knowledge and understanding of drug development processes and applicable GCP/ICH/FDA regulations and guidelines, including those for development of computerized systems for clinical research.
    • Experience in conducting and hosting audits and managing follow up to audit close.
    • Knowledge of computer systems development and validation methodology, and clinical data management and biostatistics processes an asset.
    • Demonstrated effectiveness in prioritizing work assignments independently and to deliver completed work within the guidelines of departmental policies and procedures.
    • Self-starter with effective organizational, presentation, documentation and interpersonal skills.
    • Proficient written and oral communication skills.
    • Computer skills in Microsoft Word, Excel and Lotus Notes.
    • Knowledge of databases (e.g. Lotus Notes), and SAS, an asset.