Position/Title: Lead / Project Biostatistician
Location: Head Office
Status: Full Time
Reports to: Director, Biostatistics and CDM
Number of Available Positions: 1
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.).
- 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.
- 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: Statistical Programmer Analyst – Levels 1 - 3
Location: Head Office
Status: Full Time
Reports to: Manager, Biostatistics and CDM
Number of Available Positions: 3
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.
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.
- 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