Introduction:
Welcome to dicentra!
We are a diverse team from a wide range of industries and backgrounds all united by one common passion: to improve the health and wellness of people around the world. Whether we are developing and executing a break-through clinical trial, issuing the required certifications to sell a product in a new country or jurisdiction, or guiding a client to help them successfully navigate through regulatory hurdles, we do it with confidence, knowing that our team is backed by incredible and wide-ranging experience and one of the highest success rates in the business. If you share our passion for improving health and wellness and want to find purpose in your work, apply now and join one of North America’s most respected brands in both the Health Sciences and Food industries.
Let’s build a better world, together!
Why join us
Best workplace
We nourish an environment devoted to honesty and fairness, trust and respect. We care deeply for our team members and take work-life balance seriously, allowing our people to decide on a schedule that best fits their life and working preferences.
Best people
We unite cross-industry professionals with a shared passion for improving people’s health and wellness. Our inspiring leaders are accessible and work eagerly side-by-side with individual employees to help them understand and achieve their objectives.
Best opportunities
We encourage our team members to continuously develop and enhance their skills and expertise. We recognize and reward courageous choices and innovative ideas that result in the growth of our people and company, and in the success of our clients.
Become a part of a purpose-driven and future-oriented business that impacts and improves millions of lives worldwide!
Job Responsibilities:
- Proposes primary and secondary endpoints, suggests hypothesis tests, estimates sample size, performs power analysis (Type II error [β]), strategizes for Type I error [α] conservation, and is accountable for any other statistical considerations required during clinical trial protocol development.
- Primary author of the clinical trial Statistical Analysis Plan (SAP) and reviews data management documents (eCRFs, database specifications, edit check specifications etc.) associated with the SAP.
Determines imputation strategies, outlier handling, implementation of parametric or non-parametric approaches, model assumptions, data transformations and any other decisions required to prepare the collected data for statistical analysis. - Performs exploratory data analysis (EDA) using industry-accepted programming environments (including open source and proprietary software) to investigate secondary and exploratory endpoints with techniques including (but not limited to): Parametric, non-Parametric, Bayesian, Bootstrapping, Stochastic, Machine Learning etc.
- Develops Tables, listings and figures (TLFs) and other reporting structures through version-controlled programming scripts.
- Authors standardized statistical and data analysis methodologies and develops statistical standard operating procedures (SOPs) in accordance with regulatory guidelines and best practices.
When applicable, provides guidance in the appropriate design and execution of randomization techniques for aspects of the clinical trial such as: IP sequence, blinding, cross-over study designs etc. - When applicable, contributes to non-typical study designs such as: interim study analysis plans, re-estimations of statistical parameters, using study data to estimate effect sizes for future trial objectives etc.
- Accountable for keeping abreast of the latest regulatory guidance and implementing best practices to produce high-quality statistical testing and data analysis of clinical trial data.
Perform other duties in supporting the data management and analysis team and/or CRO team as assigned by management, and as delegated by the Principal Investigator (PI).
Job Qualifications
Minimum
- Master’s degree in Statistics, Biostatistics or a closely related field (with considerable exposure to statistical, mathematical and/or computing-related material).
- 2+ years of demonstrable experience handling clinical trials and/or clinical research projects from statistical design to data/statistical analysis and reporting.
- Proficiency in the use of a variety of statistical procedures such as parametric testing, non-parametric analysis, multiple linear regression, categorical data analysis, survival analysis, ROC curves etc.
- Ability to use open source programming languages (R, python) and commercial statistical packages, (SAS, SPSS) for data analysis, statistical testing and report generation.
- Experience in estimating effect sizes and providing rationales for parameter selection in power analysis/sample size estimations.
- Superior analytical skills and attention to detail, particularly in wrangling datasets, producing summary tables and figures, and performing code reviews.
- Excellent communication skills, with an ability to educate and discuss complex statistical topics with technical and non-technical audiences.
- Proficient in MS Office Suite programs, Cloud service tools (Google suite, MS SharePoint) and communication tools (Teams, Outlook, Slack etc.)
- Must be fluent in English and possess excellent oral and written communication skills.
Preferred
- Accreditation as a statistician, or, demonstrable eligibility for designation through a recognized statistical society (SSC, ASA etc.).
- Clinical research organization (CRO) experience; or, relevant industry-related experience working on clinical/healthcare-related projects is strongly preferred.
- In-depth knowledge of frequentist approaches to the analysis of healthcare-related data, including approaches to topics such as: the multiplicity (multiple comparisons) problem, missing/corrupt data imputation, outlier investigation, transforming skewed distributions, model assumption violations etc.
- Familiarity with ICH-GCP Guidelines and Regulations (Health Canada, FDA, EMA and other regulatory bodies) as they pertain to clinical trials; Basic knowledge of GCDMP practices is an asset.
- Familiarity with guidance on statistical considerations for clinical trials, multiple endpoints, bioequivalence studies, medical device trials, emergency use authorizations (EUAs) etc. is highly desirable.
- Comfort in using R, Python, GitHub and/or any other open-source programming languages and version control platforms is an asset.
- Familiarity with CDISC data standards, in particular ADaM and SDTM guidance for TFL generation is desirable.
- Experience developing Statistical Analysis Plans (SAPs) and other documentation relevant for clinical trial design and reporting for submission to sponsors and regulatory authorities is preferred.
- Familiarity with Electronic Data Capture (EDC) systems and basic database (relational, unstructured) build and storage principles is an asset.
- Exceptional interpersonal communication skills and a high degree of professionalism; Ability to communicate effectively with project sponsors and internal/external stakeholders.
- Ability to work individually and as part of a team in a dynamic, efficient clinic, office, and/or remote setting.
- Accountable and accurate with a strong sense of teamwork, including ad-hoc problem-solving abilities during unexpected circumstances.
- Comfortable handling sensitive and private information while multi-tasking and working in a fast-paced, team-oriented environment.
In addition to the skills and qualifications above, we value the following qualities in all of our team members:
- High-quality standards, responsibility, and engagement.
- Ability to interact with a range of personalities and many levels of the organization.
- Demonstrated self-motivation and the ability to take the initiative.
- Project management and strong prioritization skills.
- Attention to and ability to execute details.
- Adaptable to changing environments, client, and project needs.
Job Type: Full-time
Location: Opportunity to work remotely or in Toronto, ON office.
Benefits Include:
- Disability insurance
- Dental Care
- Extended health care
- Life insurance
- Vision care
- Wellness program
- Work remotely/optional