Assistant Manager, MfgS&Tch-ARPL-MS&T AR

Job Summary

Statistical Support is an integral requirement during the technology transfer of products and during the product life-cycle management. This role is responsible and accountable for providing Statistical Support to MS&T within the ARPL and GTA. This group is also responsible for driving consistent statistical approaches across the manufacturing sites. The Assistant Manager - Statistical Support acts as a project leader, overseeing the approach to and resolution of all technical issues related to MS&T 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 experimental and validation protocol 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.
• Determines point and interval estimates and applies sound statistical methodology in performing risk assessments and optimization/validation plans.
• Investigates out of specification or out of trend results.
• Leads projects providing statistical support for to evaluate any changes during the life cycle of a product. Such changes may include formulations, analytical method, raw materials, and manufacturing processes.
• Oversees statistical activities, such as JMP, 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 MS&T department and other departments, as needed.
• 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: Integrity, Teamwork, Courage and Innovation
• All other relevant duties as assigned.

Job Requirements

• Education
  • Graduation in Mathematics (Statistics) or related Pharmaceutical/Engineering subjects.
    
    
• Knowledge, Skills and Abilities
  • Extensive knowledge and experience in applied statistics
  • Strong verbal and written English communication skills
  • Knowledge on pharmaceutical oral solid dosage processes, formulation and equipment
  • Excellent organization, troubleshooting, report writing and analytical skills.
  • Intermediate to Advanced level of computer skills in Microsoft Office (Word, Excel,PowerPoint and Outlook)
  • 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 Eight years of successful working experience in a regulated industry (preferably Pharmaceutical) with related experience in supporting statistical analysis and evaluations.