Senior Statistical Programmer
Our client is a leading pharmaceutical and biotechnology research organization. Due to company growth they have asked Bryan Forrest of Lock Search Group to assist them in their search for Senior Statistical Programmers to join their team (multiple positions available).
This position can be based out of their Markham location or remote/work from home.
- Lead projects with higher level of complexity/challenges/difficulties. Lead efforts to resolve complex statistical programming issues or problems.
- Perform a leadership role in statistical programming projects by coordinating study teams, overseeing timelines, assigning and following up on programming tasks, interacting with clients, and ensuring quality of programming deliverables.
- Assist statistical programming management in properly planning and allocating resources based on timelines, statistical programmers’ skills and expertise, as well as availability.
- Participate in developing and maintaining clinical trial data and statistical programming standards to ensure the company standards are up to date and in line with pharmaceutical industry standards, conventions, and regulatory requirements.
- Perform hands on primary statistical programming and validation programming on assigned projects including but not limited to phase I – IV clinical trials, integrated clinical summaries, responses to requests from regulatory agencies, publication support, data explorations, data monitoring committee meetings, etc.
- Create SDTM mapping specifications and ADaM data specifications. Perform quality control (QC) review of these documents prepared by others.
- Perform QC review/assessment on regulatory submission programming documents, datasets, tables/listings/graphs, and computer programs, etc.
- May lead programming efforts for drug development programs or for assigned client clusters.
- Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming.
- Monitor the compliance and adherence to the established data and programming standards, and statistical programming governing documents.
- M.Sc., M.A. or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields.
- 10 (M.Sc., M.A.)/9 (Ph.D.) years' related experience.
- An in-depth knowledge of clinical trial data processing and manipulation, hands on statistical programming and analysis, requirements for assembling and presenting trial results to regulatory agencies. Knowledge of industry standards on how clinical trial data are structured, stored, analyzed, and presented. Knowledge of clinical trial regulatory and ICH requirements.
- Must demonstrate ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data and results to regulatory agencies. Must possess in-depth level understanding of the concept of standardization in data, programming, and statistical reporting of trial results, and its implication to the relevant functions and operations.
- Must have sound technical judgment and experience in process design and implementation in relevant areas.
To apply, please submit a copy of your resume in confidence to Bryan Forrest via the “apply now” button.