Pulse Infoframe Inc. builds and operates the heathie ™ Platform for collecting clinical Real World Data (RWD) and generating Real World Evidence (RWE). The company has been doing this work for over a decade and has industry-leading expertise. Healthie ™ 2.0 is our current, unified platform. The Pulse Platform is the underlying data and analytics engineering framework to support the heathie™ product and essential to its success.
The Clinical Data Science team based in London, Canada is seeking a seasoned epidemiologist or biostatistician with strong hybrid biostatistics/epidemiology background to lead and support the Biostatistics and Epidemiology team on priority client projects. The position is either in our head office or remote in North America. You will collaborate with senior executives within the Pulse organization as well as key client leaders and stakeholders. The ideal candidate for this role has a complete understanding of the full research lifecycle, exceptional analytical skills, a background in clinical sciences, a passion for innovation, dependable and can work independently.
· Provide technical leadership and operational oversight to lead and orchestrate all biostatistics and epidemiology functions through full study cycle from study ideation to dissemination of results with complete clinical relevancy to the hypothesis.
· Lead both registry and study protocol designs and statistical analysis plans (SAPs) for longitudinal registry studies and publishing.
· Support key data management activities (e.g., data quality and enrichment, linking disparate data) to support internal processes and subscription reporting for external clients.
. Prior experience working within a relevant research organization/institution including pharmaceutical industry and/or regulatory agencies.
. Experience responding to requests from national regulatory agencies in the United States, Europe or other countries related to risk management planning, and/or design/implementation and reporting of post-marketing safety studies.
· Champions all data quality dimensions—integrity, timeliness, completeness, accuracy, validity, uniqueness, currency, consistency, and clinical relevancy.
· Communicate effectively statistical concepts to non-statistical audience.
· Demonstrate business, scientific and clinical acumen.
· Collaborate and support team members on complex project deliverables.
· Provide project management support. Organize and lead meetings. Ensure on-time deliverables.
· Work closely with clinical product management in the definition and delivery of projects.
· Conceptualize real-world clinical pathways and patient journeys; reconcile them with protocols and statistical analysis plans.
· Ensure workflow is conducted in a manner that is compliant with GCP, HIPAA, GDPR and RWE regulatory expectations.
· Masters in Biostatistics, Epidemiologist or similar; PhD highly preferred.
· Minimum 7 years of experience in analysis of clinical data required.
· Knowledge of oncology, rare diseases and medical sciences preferred.
· Prior established experience consulting and working with clinicians and pharmaceutical companies on research initiatives.
· Work collaboratively with various stakeholders to gain consensus within the team and across multi-functional groups outside the Biostatics& Epidemiology group.
· Minimum 5 years of experience with R (or Python, SAS); working experience with R strongly preferred.
· Strong analytics and analytics visualization experience.
· A willingness to work outside their standard comfort zone working cross-functionally to deliver internally and/or external clients.
· Experience and comfortable with the challenges of a start-up either as a new company or within a larger organization.
· Self-starter, self-sufficient, multi-tasker and highly foreword-thinking in technical environment, thrives in fast paced start-up environment, professional maturity, and discrete.
· Excellent organizational and verbal/written communications skills.
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