Statistical Support Scientific Leader

**About Apotex Inc.**

**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.

**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.
- 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.
- 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**:

- University degree in Mathematics (Statistics); SSC/ASA member in good standing with P Stat professional accreditation would be an asset.
- Minimum of five 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.
- SAS, JMP and related statistical software proficiency would be an asset.
- Intermediate to Advanced level of computer skills in Microsoft Office (Word, Excel, PowerPoint and Outlook).
- Strong verbal and written English communication skills
- Excellent organization, troubleshooting, report writing and analytical skills.
- Well-developed interpersonal and team skills.
- Multi-tasking and project management skills
- Ability to make timely evaluations which are appropriately supported by data

**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. Accommod