Careers

Our quality of our personnel is reflected by our success. We are committed to investing in the development and support of our personnel. We believe that our people are our strength. We are always looking for people with strong technical and academic backgrounds, complemented by leadership skills, to join our team. We are an equal opportunity employer and support diversity in our workplace.

The following  opportunities are currently open for qualified applicants. Please take a few moments to review the positions. We look forward to expanding our team with new leaders.  To apply please e-mail, fax or mail your cover letter and resume to:

Human Resources

SCiAN Services Inc.
4174 Dundas Street West, Suite 300
Toronto, Ontario, M8X 1X3

Fax: 416-231-1422

Email: humanresources@SCiAN.com

Position/Title: Principal Biostatistician / Consultant
Location: Head OfficeStatus: Contract - Part-time
Reports to: Director, Biostatistics and CDMSubordinates: None
Number of Available Positions: 1 

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 be responsible for providing statistical expertise across major therapeutic areas (oncology, CNS, infectious disease, immunotherapy, stem cell and gene therapies, etc.), including response to statistical issues arising in high-pressure/impact regulatory settings and from Sponsors.

 Key Responsibilities

  • Provide statistical expertise for clinical studies and clinical development programs including protocol development, study design, sample size and appropriate statistical methodology
  • Review study protocols and author statistical sections of protocols and clinical study reports
  • Handle requests from regulatory agencies with minimal guidance
  • Develop/understand innovative/creative statistical/technical solutions to complex problems
  • Statistician for DSMB/IDMC
  • Mentor statistical staff. 

Qualifications

  • PhD. in Statistics/Biostatistics
  • 5+ years experience working IND stage clinical trials for Pharma/Biotech industry
  • Expertise in statistical methodologies such as predictive modeling, mixed effects models, adaptive designs, Bayesian statistics, etc.
  • Experience interacting with FDA and Regulatory agencies on statistical issues
  • Knowledge of FDA and ICH regulations and guidelines
  • Strong computing skills in SAS or other programming languages
  • Effective written and verbal communication skills.
Position/Title: Lead / Project Biostatistician
Location: Head OfficeStatus: Full Time
Reports to: Director, Biostatistics and CDMSubordinates: None
Number of Available Positions: 2 

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
  • Experience with CDISC standards including 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: Statistician / SAS Programmer – Entry Level and Intermediate
Location: Head OfficeStatus: Full Time
Reports to: Manager, Biostatistics and CDMSubordinates: 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
  • 0 to 3 years experience in statistical programming (SAS preferred) in the Pharma/Biotech industry
  • 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: Clinical Data Manager
Location: Head Office, Toronto OntarioStatus: Full Time
Reports to: Director, CDM & BiostatisticsSubordinates: None
Number of Available Positions: 1 

Summary

This job description defines our requirements for an intermediate to senior level.

SCiAN's EDC-CDM Group is responsible for the data management activities associated with IND-stage phase I - III clinical trials of our North American and International Clients covering indications including oncology, CNS, infectious disease, immunotherapy, stem cell and gene therapies, etc. EDC solutions supported by SCiAN include both SCiAN's propriatery edcpro platform and hosted 3rd-party systems.

The successful candidates will lead SCiAN's internal EDC-CDM project teams and will support and guide the Clinical Project Managers, CRAs, Study Coordinators and Specialists to ensure delivery of quality study data on time, on budget and to client specifications. He/She may also be called on to provide data management expertise for other project teams.

Key Responsibilities

On a project-by-project basis:

Project Management:

  • Establishes the EDC-CDM sections of the project management plan per the  scope of work, study protocol, Sponsor requirements and SCiAN standards
  • Ensures that all CDM activities defined in the project management plan are executed and completed per the project schedule and scope
  • Trains and manages SCiAN's internal project team. The team is comprised of 2-5 members: a combination of clinical application programmers, data reviewers, medical coders; SAS / statistical programmers, medical reviewers, and drug safety specialists
  • Responsible for maintaining the project management plan, tracking and issue log(s), and for reporting to management on study progress and the performance of the project team
  • Manages day-to-day client interaction and status reporting
  • Communicates effectively with clients to identify needs and solve any issues that arise.
  • Ensures SCiAN's standards are upheld
  • Reviews project deliverables prior to sending to the client.

Clinical Data Management:

  • Liaises with Sponsor and designees on database design and functionality; compiles and maintains study database requirements and responsible for the development of configuration plan and data management plan
  • Oversees design, implementation, testing and deployment of the study database and ensures completion of associated documentation
  • Oversees development and maintenance of EDC user guide and other study database documents (e.g. FAQ)
  • Conducts and manages end-user training (internal and external end-users)
  • Responsible for monitoring database access, data integrity, usage, performance of edit checks, and recommends changes per these monitoring activities
  • Oversees help desk and database change management activities
  • Manages data transfers from 3rd parties and interim data exports
  • Manages final database lock and audit activities including SAE reconciliation AE/CMED coding and others as defined in project scope
  • Ensures the database documentation is consistent with study database, and manages the release of the database and database documentation as per SciAn SOPs.
  • Oversees project closure activities (e.g. decommissioning of EDC system, release of eCRFs to sites, etc.).

Qualifications

Required:

  • A degree in health or data/mathematical/statistical sciences
  • Minimum of 3 years of experience in clinical data management projects in an EDC setting
  • In-depth understanding of database structures and database programming  
  • Solid knowledge of clinical trial processes, ICH GCP, and GCDMP (SCDM) and CDISC
  • Able to alternately lead and work as part of a multi-disciplinary team
  • Able to effectively communicate with internal and external stakeholders
  • Strong oral and written communication skills
  • Good presentation and training skills
  • Self-motivated, with the ability to learn quickly and independently
  • Demonstrated ability to problem solve
  • Intermediate MS Office 2007 skills (Word, Excel, PowerPoint).

Desired:

  • SCDM Certification
  • PMP certification or demonstrated project management experience / education
  • Experience with Domino/Lotus Notes
  • Knowledge of software development life cycle
  • Experience working in a regulated company.
Position/Title: Clinical Data Associate – Intermediate (CRAs Invited)
Location: Head Office, Toronto OntarioStatus: Full Time
Reports to: Manager, CDM & BiostatisticsSubordinates: None
Number of Available Positions: 2 

Summary

SCiAN's EDC-CDM Group is responsible for the data management activities associated with IND-stage phase I - III clinical trials of our North American and International Clients covering indications including oncology, CNS, infectious disease, immunotherapy, stem cell and gene therapies, etc. EDC solutions supported by SCiAN include both SCiAN's proprietary EDCPRO platform and hosted 3rd-party systems.

The successful candidate will contribute to SCiAN's internal EDC-CDM project teams in all data management activities. 

Key Responsibilities

On a project-by-project basis:

  • Assist in study set-up, maintenance and completion activities under the supervision of the Project Manager.  This includes develop project documents such as the DMP and DVP.
  • Perform quality control on: study documentation, query generation and integration, discrepancy management, etc. to ensure quality standards are maintained
  • Perform clinical data review, query generation / resolution and reconciliation activities in accordance with DVP and DMP
  • Perform reconciliation of the clinical database against external/third party data, such as central laboratory and PK data
  • Plan and conduct EDC end-user training
  • Participate in Sponsor meetings
  • Perform medical coding of medical conditions, adverse events and concomitant medications
  • May serve as the back-up for the Project Manager for EDC-CDM studies
  • Assure quality of personal work.

 Qualifications

  • BSc. or MSc.in Life sciences or related field
  • 2+ years experience in clinical data management or 5+ years as a CRA
  • Experience with EDC studies and EDC systems
  • Experence working in a regulated environment
  • Knowledge of ICH, GCP guidelines
  • Effective written and verbal communication skills
  • Experience in medical coding dictionaries an asset
  • Cooperative and team-oriented
  • Self-motivated and detailed-oriented
  • Ability to work to tight deadlines while maintaining high standards
Position/Title: Clinical Data Associate – Entry Level (CRAs Invited)
Location: Head Office, Toronto OntarioStatus: Full Time
Reports to: Manager, CDM & BiostatisticsSubordinates: None
Number of Available Positions: 2 

Summary

SCiAN's EDC-CDM Group is responsible for the data management activities associated with IND-stage phase I - III clinical trials of our North American and International Clients covering indications including oncology, CNS, infectious disease, immunotherapy, stem cell and gene therapies, etc. EDC solutions supported by SCiAN include both SCiAN's proprietary EDCPRO platform and hosted 3rd-party systems.

The successful candidate will contribute to SCiAN's internal EDC-CDM project teams in all data management activities.

Key Responsibilities

On a project-by-project basis:

  • Perform clinical data review, query generation / resolution and reconciliation activities in accordance with DVP and DMP
  • Perform reconciliation of the clinical database against external/third party data, such as central laboratory and PK data
  • Conduct EDC end-user training
  • Provide help desk support to Site Coordinator, Monitors and Sponsors for EDC studies
  • Assist in QC activities to ensure database meets standards/expectations of SCiAN and Sponsor
  • May assist with medical coding of medical conditions, adverse events and concomitant medications
  • Assure quality of personal work.

Qualifications

  • BSc. in Life sciences or related field
  • 0 to 2 years experience in clinical data management or 3+ years as a CRA
  • Understanding of database structures, basic programming skills
  • Effective written and verbal communication skills
  • Knowledge of ICH, GCP guidelines preferred
  • Experience with EDC studies an asset
  • Experience in medical coding dictionaries an asset
  • Cooperative and team-oriented
  • Self-motivated and detailed-oriented
  • Ability to work to tight deadlines while maintaining high standards.