Clinical Statistician programmer/Oncology - URGENT 20 hours/week ( Part Time) 

Role

The clinical statistical programmer will be responsible for providing study level statistical expertise hand to hand with the other statistical team member

The clinical statistical programmer will also be responsible for Providing statistical programming expertise to the development, validation and supporting Clinical development and Medical team.

Profile :

• You must be Canadian  (or have a Canadian work permit).
• You have a good understanding of applied statistical principles in the design and analysis  clinical studies.

• You hold a university level degree in Sciences, Engineering or Mathematics with a graduate degree in Biostatistics or equivalent educational background.
• You have a minimum of 2 years of experience in clinical statistical programming or equivalent experience.
• You are very reactive
• You are a team player, good communicator and have a collaborative attitude
• You have the ability to work with minimal supervision.
• You have strong attention to detail and are comfortable managing multiple projects at once
• You have the ability to liaise theory with the practical translations
• You have the ability to share knowledge and interact within multidisciplinary teams.
• You have experience in providing submission-related study support.
• You carry experience in statistical or clinical trial methodology research and presentations on statistical methods, clinical trial design, and analysis in either observational studies.
• You are extremely proficient in SAS programming (knowledge of other statistical software is an asset).
• If you have CDISC knowledge, it will be considered as a an asset.
• 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.

Key Responsibilities:

• Programming deliveries through preparation of clinical datasets for regulatory submissions.
• Writing and executing SAS programs for data analysis and reporting.
• Performing statistical analysis such as normalization, linear regression, non-linear regression and hypothesis testing for different biological assay data with various plates formats in drug discovery process.
• Responsible for statistical programming activities. That includes, but is not limited to: analyzing, integrating and reporting of clinical trial data in order to produce quality and timely deliverables.
• Responsible for statistical programming activities in order to produce adequate and timely deliverables.
• Provide statistical programming support for clinical studies through generation of derived analysis data sets, tables, listings, and figures, including quality control of those documents.
• Participating in operations meetings and address issues that may influence statistical programming and data management.
• Coordinating programming activities for the client
• Development/validation of study specific and cross project macros
• Performing/validating statistical analysis and compiling those into statistical reports including interactive graphical outputs.
• Input in standard processes (review of Standard Operating Procedures, guidelines, definition of new processes needed)

Initial length of contract: 20 hours/week ( but might be growing with time) 1 year and renew each year

Start date : as soon as possible.

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.