UBC are a leading provider of pharmaceutical support services, partnering with life science companies to demonstrate value, ensure safe use and accelerate patient access to innovative medical products. Our services range from supporting the largest brands in the industry, to providing fully outsourced functional services, to the most recently approved genetic therapies in orphan populations. The work we do positively impacts patients’ lives all over the world.
This role is part of our FSP model and on a 12 month renewable contract
Brief Description:
As a Sr Scientist – Epidemiology/RWE and Biostatistics, Health Harm Reduction, you will provide expertise in statistical methods, practices, and theory to design, conduct and report RWE and clinical research studies to understand the health impact of products in our portfolio. You will work closely with other functions to formulate questions and answer them in applying industry standards. You will translate strategic needs into innovative statistical solutions, ensuring timeliness, quality, completeness, report results according to regulatory framework, as well as interact with Clinical Research Organizations (CROs), follow-up budget and lead resources.
Specific job duties:
Act as an epidemiology/RWE & statistical methodology expert for the assigned studies. Ensure that regulatory guidance on design, conduct, and reporting (e.g., ICH, EMA and FDA guidance on RWE, STROBE) and internal quality processes pertaining to statistical principles are followed for the assigned studies. Provide statistical expertise on GCP and GEP principles, and guide study team through the processes to follow. Serve as a technical leader in biostatistical science. Guide and supervise the selection of appropriate statistical methodologies for study design and data analysis to ensure evidence generation of the highest scientific quality. Interact with the Study Team and mentor them on statistical issues to best support the objectives. Apply biostatistical and quantitative epidemiological principles, techniques, and practices to develop methodology to assess alternative products. Maintain an up-to-date knowledge of methodology and regulations. Oversee all study statistical aspects by reviewing and approving all statistical deliverables of the assigned studies. Bring statistical input in all study related documents and in communication with authorities. Lead CROs, track progress of statistical activities against agreed timelines to ensure that all appropriate activities have been performed and delivered on time with the expected quality. Provide expertise to the R&D program pre- and post- marketing studies. Participate in the writing, review, and update of quality documents.
Supervisory Responsibility:
Potential if project load increases
Desired Skills and Qualifications:
MSc/PhD degree (preferred) in pharmacoepidemiology and biostatistics, or equivalent skills through demonstrated experience. Substantial experience in pharmaceutical, medical devices, consumer goods, or a clinical research environment is required. Proficiency with R or SAS is required. Knowledge of CDISC (SDTM, ADaM) and OMOP are an advantage. Interest in analyzing big datasets such as electronic medical records using machine learning algorithms is an advantage. Excellent interpersonal communication, organizational and leadership skills with ability to work both independently and in a team environment are required. Ability to mentor other team members is an advantage. Proficient with Excel, PowerPoint, and Word is required. Fluent in English, both written and spoken is required.
