Biostatistician Consultant

Biostatistician Consultant

February 9, 2022 By

Introduction:

We are currently seeking an analytical and detail-oriented Biostatistician Consultant to join our growing firm. The successful candidate will provide statistical input in two major aspects of the clinical trial process: 1) Design of the statistical approach to proposed endpoints in clinical trial protocols and 2) Develop statistical methodologies for the analysis and reporting of clinical trial data. You will contribute to the Statistical Analysis Plan (SAP) and other data management-related documentation to ensure that high-quality data is captured for effective statistical data analysis. You will interpret regulatory guidance on statistical considerations for a diverse range of clinical trials and ensures that dicentra’s data and statistical analysis workflows adhere to them. 

Let’s build a better world together. Apply now!

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:

  • Performs statistical reviews and input to drafted endpoints, proposed hypothesis tests, sample size estimation and power analysis (Type II error [β]) calculations, Type I error [α] conservation strategies, and any other statistical considerations required during clinical trial protocol development.
  • Contributes to the clinical trial Statistical Analysis Plan (SAP) and reviews applicable ancillary documents (eCRFs, database specifications, edit check specifications etc.) associated with the SAP.
  • Accountable for interpreting and implementing the appropriate regulatory guidance for the design and conduct of data/statistical analysis for clinical trial projects.
  • Provides direction for 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.
  • Ensures that appropriate exploratory data analysis (EDA), tables, listings and figures (TLFs) and other items deployed through statistical programming scripts have been accurately developed.
  • Performs critical review of, and provides input to the interpretation of clinical trial data, in accordance to the clinical trial protocol, SAP and applicable regulatory requirements; reviews the final documentation submitted to regulatory bodies to ensure accuracy in communicating the outcomes.
  • Aids in the development of standardizing statistical methodologies and/or developing statistical standard operating procedures (SOPs).
  • When applicable, provides training and direction in implementing non-traditional frequentist approaches to statistical testing of data; for example, using bootstrapping approaches, Bayesian inference techniques, MCMC simulation or other methodologies that could supersede traditional frequentist approaches to satisfy sponsor, trial protocol and/or regulatory requirements.
  • When applicable, designs and executes randomization for aspects of the clinical trial such as: IP sequence, blinding, cross-over study designs etc.
  • When applicable, provides consultation on 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 handling of clinical trial data at dicentra.
  • Perform other duties in supporting the data team and/or CRO team as assigned by management, and as delegated by the Principal Investigator (PI).

Job Qualifications 

  • Master’s degree in Statistics, Biostatistics or a closely related field (with considerable exposure to statistical, mathematical and/or computing-related material).
  • 3+ years of experience working as a statistician/statistical analyst, with demonstrable experience leading statistical projects from design to 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 statistical computing software packages, including commercial (SAS, SPSS) and open source languages (R) 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.
  • In-depth knowledge of frequentist approaches to the analysis of healthcare-related data, including approaches to issues such as: the multiplicity (multiple comparisons) problem, missing/corrupt data imputation, outliers, skewed distributions, violations of model assumptions, etc.
  • Superior analytical skills and attention to detail, particularly in reviewing datasets, summary tables, figures and code review.
  • Excellent communication skills, with an ability to educate and discuss complex statistical topics to technical and non-technical audiences.
  • Must be fluent in English and possess excellent oral and written communication skills.
  • Clinical research organization (CRO) experience; or, relevant industry-related experience working on clinical/healthcare-related projects is strongly preferred.
  • 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 use of 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.
  • Proficient in MS Office Suite programs, communication tools (Teams, Outlook etc.); familiarity with CTMS and EDC systems is an asset.
  • Exceptional interpersonal communication skills and 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 team-work, including contribute to various aspects of project deliverables and problem-solve 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 initiative.
  • Project management and strong prioritization skills.
  • Attention to and ability to execute details.
  • Adaptable to changing environment, 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

Applying:

To be considered for future opportunities, please email your cover letter, resume/CV, and any related supporting documentation to hr@dicentra.com with “Biostatistician Consultant” in the subject line.

As part of the hiring process, in addition to interviewing, successful candidates may be required to complete a skills assessment and a reference/background check. If you are sent a skills assessment, please complete it for consideration for the advertised position.

We thank all applicants for their interest, however, only those selected for an interview will be contacted.