Position/Title: General Manager
Location: Head Office
Status: Full Time or Part-Time (minimum 28 hours)
Reports to: President & CEO
Subordinates: Executive Assistant; Quality Assurance; IT Systems
Number of Available Positions: 1
Summary
The successful candidate manages the company’s day-to-day functions, ensuring the efficient and cost-effective use of resources. He/She fosters strong employee relations and the achievement of financial goals, ensuring that all employees comply with regulatory, client, corporate, and regional policies and procedures, while supporting a culture of accountability and professional conduct.
Qualifications
- Master's Degree or Higher
- Direct GM work experience in an ‘agile’ CRO or IT /Software Development setting
- Experience in managing teams in a professional, B2B business: managing expert personnel in different functional departments of a small business
- Fully functional user of all business applications (MS Office, MS Projects or other project management software; Accounting apps, etc.) and ability to learn new apps quickly
- Accounting, budgeting and general project management skills;
- Knowledge of quality assurance and quality systems as it relates to the CRO business model is an asset;
- Extensive knowledge of the drug development process and experience in working in health sciences, the pharmaceutical or biotech industries, or academic/hospital research groups is an asset;
- Minimum ten years service business management experience;
- Strong written and oral communications skills; excellent public relations and networking skills;
- Capacity to plan and organize workload expectations in a complex service business; ability to accept responsibility and demonstrate accountability.
Key Responsibilities
- Develops strategic plans by studying technological, financial and service opportunities; presenting assumptions; recommending courses of action.
- Establishes plans, budgets and results measurements; allocating resources; reviewing progress; making mid-course corrections to achieve company goals.
- Coordinates company resources by establishing procurement, production, marketing and professional technical services, policies and procedures.
- Builds and maintains a positive company image by collaborating with customers, regulatory agencies, employees, community organizations, as well as through media and promotional services providers.
- HR functions: orienting, coaching, counseling and disciplining staff; communicating ethics and values, strategies and objectives; assigning accountabilities; planning, monitoring and appraising job results; developing incentives; supporting a climate for offering information and opinions; providing educational opportunities.
- Oversees routine IT, QA and Accounting department tasks.
- Oversees project/study budgets: planning, tracking, invoicing, internal performance reviews and subsequent corrective actions.
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.).
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.
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.
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.
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
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.
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.
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.
- Understanding of IT Security and Data privacy standards and procedure.
- Knowledge of 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.
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 initial and ongoing supplier 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.