St-analyst, Biowaivers, Biocorrelation and

2 weeks ago

North York, Canada Apotex Inc. Full time

**About Apotex Inc.**

**Job Summary**:
Acts as a part of a multifunctional team focused primarily on development of new drug products as solid dosage forms.

The Incumbent will have the opportunity to learn about biopharmaceutical aspects of the development of the new drug product, data analysis and Regulatory requirements. Additionally the incumebent will gain knowledge related to statistical approaches in assessment of various pharmaceutical data in support of development, process improvements and investigations.

**Responsibilities**:

- Data compilation, data entry and data checks
- Literature searches and literature reference verifications
- Drug release/Dissolution data plotting and dissolution profile similarity calculation
- Assist in drug release and absorption modelling and IVIVC correlations using computer software
- Assist in compilation and formatting of technical report
- Statistical analysis such as bivariate analysis, ANOVA, linear regression, and multivariate modelling
- Assist in preparation of regulatory submission documents
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.

All other relevant duties as assigned.

**Job Requirements**:

- Education
- Enrolled in undergraduate (BSc) or postgraduate (MSc) studies in Pharmaceutical, Pharmacology, Chemistry or related sciences.
- Knowledge, Skills and Abilities
- Excellent verbal and written communication skills
- A demonstrated ability to prioritize and achieve results while managing multiple concurrent tasks
- Must be timeline driven
- Must work well under pressure
- Desire to learn and contribute to team goals is a must
- Must have the ability to work independently as well as work well in a team setting
- Must have solid Microsoft Office skills (such as MS word, Excel and PowerPoint)
- Must have a solid Pharmaceutical background (e.g.Pharmaceutics, Pharmaceutical chemistry, Biopharmaceutics, Pharmacokinetics)
- Understanding of statistics or biostatistics
- Experience
- Previous courses/training in statistics or biostatistics preferred
- Previous courses/training on pharmacokinetics or bioequivalence is an asset

Exposure and understanding of statistics or biostatistics

**COVID-19 VACCINATION POLICY**:In accordance with Apotex Inc. (“Apotex”) policy, as of November 15, 2021, all individuals entering a Canadian site (including but not limited to employees, visitors, contractors and agency workers) must be fully vaccinated against COVID-19 in accordance with the current government requirements. Further, all employees must maintain all future booster vaccines as approved and recommended by Health Canada. Accommodation from these requirements for reasons pursuant to the Ontario Human Rights Code, or any other applicable law (most commonly for medical and/or religious reasons) will be reviewed and considered by Apotex.

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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