Statistical Support Scientific Leader

Job Summary

Statistical Support is an integral requirement  during  the development and lifecycle of new pharmaceutical products.

This role is responsible and accountable for providing Statistical Support for new product  development  groups within  the GTA. This group is also responsible  for the Apotex GRD Statistical Certification Program and driving  consistent statistical approaches across the manufacturing sites.

The Scientific Leader, Statistical Support acts as a project leader, overseeing the approach to and resolution of all technical issues related to GRD tasks by implementing sound statistical methodology.

Job Responsibilities

• Contributes to decision making on study design, data collection, and analysis by independently recommending appropriate statistical methodology, ensuring alignment with study objectives and regulatory guidelines.
• Oversees sample size determinations for unique or complex study designs.
• Contributes to the development and authoring/review of the statistical methods section of unique or complex protocols and reports, and writes statistical analysis plans, when necessary.
• Works with internal stakeholders to define specifications and acceptable ranges, and to design suitable experiments using Design of Experiment methodology.
• Determines point and interval estimates, and applies sound statistical methodology in performing risk assessments and optimization plans.
• Investigates out of specification or out of trend results.
• Leads projects providing statistical support for DoE trials in order to evaluate changes in formulations, analytical method, raw materials, and manufacturing processes.
• Oversees statistical activities, such as JMP use or SAS programming, of more junior staff.
• Liaises with internal stakeholders to determine data attributes, or formatting, required to obtain data for tables, listings and figures.
• Contributes to the preparation of statistical justifications, and writes responses to complex issues, applying concise, creative and sound scientific and statistical interpretation of literature or data, often with a tight deadline.
• Provides professional and technical advice in statistics with the ability to mentor more junior staff, and explain statistical concepts to non-statisticians to enhance their understanding.
• Provides statistical expertise and performs consultations on issues regarding process optimization, process improvement, optimum utilization of equipment, and general statistical best practice to other members of the GRD department and other departments, as needed.
• Contributes to the development and maintenance of the Apotex GRD Statistical Certification Program.
• Provides guidance to junior statistical support staff on technical and statistical support for product submission documents for all major process changes.
• Contributes to defendable justifications and whitepapers on novel assessment tools and statistical methodologies/approaches.
• Provides professional expertise and takes a senior role in offering statistical support services and innovative solutions and implements tools to help the group achieve expectations and goals.
• Keeps abreast of the changing regulatory landscape relating to study design, data analysis and reporting.
• Participates in regulatory inspections, and represents Apotex’s interests at regulatory or scientific meetings.
• Takes a lead role in the recommendation of revisions to support the continuous improvement of departmental processes and SOPs.
• Performs all work in compliance with our Code of Conduct and Business Ethics, and related policies and with the legal and regulatory requirements that apply to our job activities;
• Works as a member of a team to achieve all outcomes;
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements;
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion and
• All other relevant duties as assigned.

Job Requirements

• Education
  • University degree in Mathematics (Statistics) or related sciences.
• Knowledge, Skills and Abilities
  • Extensive knowledge and experience in applied statistics
  • Strong verbal and written English communication skills
  • Excellent organization, troubleshooting, report writing and analytical skills.
  • Intermediate to Advanced level of computer skills in Microsoft Office (Word, Excel, PowerPoint and Outlook)
  • SAS, JMP and related statistical software proficiency is a must.
  • Well-developed interpersonal and team skills.
  • Multi-tasking and project management skills
  • Ability to make timely evaluations which are appropriately supported by data.
• Experience
  • Minimum of five years of successful working  experience in a regulated industry (preferably Pharmaceutical) with related experience in supporting  statistical analysis and evaluations.