Study Lead Clinical Statistician
Role
The Study Lead Clinical Statistician will be responsible for supervising/managing, overseeing and validating all statistical activities of a dedicated team of statisticians at the project and study levels.
The Study Lead Clinical Statistician will also be responsible for providing statistical expertize to the development, validation and quality monitoring of biological assays supporting clinical development of Global Health Projects.
Profile :
- You must be a Canadian or American resident (or have a Canadian or American Work Permit)
- You hold a University level degree in Sciences or Engineering with a M.Sc. or PhD degree in Biostatistics or equivalent educational background
- You have at least 5 years of experience as biostatistician in the Pharmaceutical field or equivalent experience.
- You have strong and positive leadership skills
- You carry experience in team management
- You are creative and innovative
- You are a team player and good communicator
- You have the ability to liaise theory with the practical translations
- You have the ability to share knowledge within multidisciplinary teams
- You carry experience in providing submission-related study support
- You have a good understanding of applied statistical principles in the design and analysis of epidemiological studies and/or clinical studies
- You have experience in statistical or clinical trial methodology research and presentations on statistical methods, clinical trial design, and analysis in either observational studies.
- If you have experience in Baysian statistics, it will be considered as a strong asset.
- Knowledge of HARP and Veeva eTMF will be considered an asset
- You are proficient in SAS and R (knowledge of other statistical software is an asset) for the programming of ad hob analysis.
- Fluency in written and spoken English
- You are used to comply with internal Standard Operating Procedures and regulatory guidelines.
- Knowledge of ICH Good Clinical Practices.
- If you have previous experience with CDISC data it will be considered a strong asset
Key Responsibilities:
- You will be responsible for validating all statistical aspects of studies developed by the statisticians’ team in collaboration with internal and external stakeholders. That includes but is not limited to:
- Delivering of SAC
- Support dose-escalation decisions
- Simulations
- Writing of statistical sections for study synopses and protocols, clinical study reports, statistical publications and clinical communications
- Offering statistical support for medical writers and clinicians
- Study set up (Case report forms, database mounting, review of datasets specifications)
- Write and execute SAS programs for data analysis and reporting
- Input in standard processes (review of Standard Operating Procedures, guidelines, definition of new processes needed)
Job Type: Full-time
Start date : as soon as possible.
Salary: 110 000 to 150 000$ per year
What we offer
At Keyrus, thanks to the expertise of our people and external partners, each employee is welcomed with a varied integration program. You will join a dynamic and international environment with enthusiastic and professional colleagues.
We invest considerable time and resources in training our staff (technical and non-technical courses) to support you in your continuous personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits ( pension and health insurance, …) based on your background and experience.
Who we are
Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our human approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Life Science we’re proud of our commitment to deliver services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better.
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
Workplace & Culture
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We're excited to invite you on to our successful journey with a strong human culture, where you can grow, improve, and magnify your talent.
About Keyrus Life Science North America
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Study Lead Clinical Statistician
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