Apotex Inc.,
Designation : Assistant Manager
Function : MS&T
Functional Area : Technology Transfer
Job Role Summary : Providing Statistical Support to MS&T within the ARPL and GTA for technology transfer of products and during the product life-cycle management, resolution of all technical issues related to MS&T tasks by implementing sound statistical methodologyÂ
Job Profile :
- 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.
- 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.
- 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.
- Contributes to defendable justifications and whitepapers on novel assessment tools and statistical methodologies/approaches
Job Requirements :
- Minimum of Eight years of successful working experience in a regulated industry (preferably Pharmaceutical) with related experience in supporting statistical analysis and evaluations.
- Extensive knowledge and experience in applied statistics
- Knowledge on pharmaceutical oral solid dosage processes, formulation and equipment
- Intermediate to Advanced level of computer skills in Microsoft Office (Word, Excel,PowerPoint and Outlook)
- JMP and related statistical software proficiency is a must.
Work / Job Experience : 8 Years
Type of Experience : Formulations technology transfer, statistical approaches
Academic Qualifications :
- Graduation in Mathematics (Statistics) or related Pharmaceutical/Engineering subjects.
