Biostatistics Programming Project Lead

3 weeks ago

Laval, Canada Servier Full time

**Date posted**:May 11, 2023**City**:Laval**Country/Region**:CA**Type of Contract**:Unlimited contract**Job Requisition ID**:3185Biostatistics Programming Project Lead

**SUMMARY OF ROLE**:

- Responsible for the development of the statistical programming on the project level, by leading multiple projects by working with local and CRO programmers with respect to statistical programming strategy and activities. Ensure the statistical programming processes are being followed by the study team and deliverables are aligned with regulatory requirement and internal procedures.**Status of position**:Permanent**Start date**: As soon as possible**Location of position: Remote**

**Specific Responsibilities***:

- **Responsibilities related to expertise**
- Responsible for overseeing deliverables on multiple projects by managing study leads and oversee study activities and vendor oversight.
- Responsible for the development and QC of analysis datasets and outputs for individual study as well as integrated analyses.
- Ensure high quality, traceability, reproducibility and timeliness of statistical programming deliverables to meet expectations and regulatory requirements.
- Mentor statistical programmers with regards to programming activities and project management.
- Collaborate with statisticians, local and CRO programmers and data managers to define and implement analysis requirements.
- Ensure an efficient collaboration with programming teams in Global Team.
- Ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements, for instance:

- Clinical study reporting, e.g. ICH E3
- Electronic records handling, e.g. Chapter 21 of the US Code of Federal Regulation - Part 11
- Electronic submission of clinical data to agencies, e.g. e-CTD guidance and CDISC SDTM and ADaM standards.
- Support on the design of new statistical programming processes or optimization of existing ones to reach the best productivity, to ensure the best quality of the statistical outputs, and to reach the best customer satisfaction (internally and externally) with flexibility, reliability and responsiveness.
- Keep abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementation.
- **Other responsibilities**
- Participate in working groups (either inter department or cross functional).
- Participate in the preparation of audit/inspection and could interact with auditors/inspectors.
- Contribute to the establishment and maintenance of common formats and templates for key Programming documentation (e.g., standard CRF pages, Tables, Figures and Listings).
- **Other duties as required or directed by the Line Manager or dotted-line Manager**
- Skills and Education- Mandatory:
- Proficient in SAS
- Good knowledge of CDISC ADaM and SDTM
- Strong understanding of drug development, including knowledge of interfaces and interdependencies with other functions
- Strong knowledge of relevant regulatory and data submission guidelines
- Self-directed, technically strong, and a recognized leader maintaining a strategic prospective with regard to statistical programming processes, management of statistical programmers and customer management
- Strong project management skills
- Good negotiation and issue resolution skills
- Ability to organize team work and prioritize and balance concurrent tasks and responsibilities. Excellent time management skills
- Ability to educate internal and external interfaces (providers and customers) on the statistical programming processes, and the underlying regulatory requirements

**Desirable**:

- Preferably at least 10 to 12 years of experience in statistical programming or biostatistics activities in the Pharmaceutical/Biotechnology industry in clinical development
- Preferably bachelor or master of science degree or equivalent in statistics or related fields
- Experience with other statistical software packages such as R, SQL, Python etc.
- Other Relevant Information:
- Some domestic and international travel required
- What We Are Offering:
- A highly dynamic team;
- A training program giving you the necessary tools to start your career with us;
- An attractive group insurance and retirement plan;
- Competitive remuneration including a performance bonus;
- A healthcare account;
- An employee assistance program;
- A sports bonus;
- Corporate values centered on employee development;
- And much more
- Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognised for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit. All this and more in a workplace focused on your well-being.- At Servier, we are

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