Biostatistician - Canada

Description

The Biostatistician will act as support or Lead Biostatistician on multiple phase 1 to 4 clinical trials, providing input into the statistical sections of protocols (incl. sample size calculation/validation), Risk-based Monitoring Plans, various Data Management (DM) documents, and statistical sections of clinical study reports (CSRs). The Biostatistician will also ensure the general financial health of clinical trials, develop Statistical Analysis Plans (SAP; incl. Table, Listing, and Figure [TLF] shells), and support teams of Statistical Programmers performing statistical analysis of clinical trial data.

The Biostatistician will work collaboratively within Biostatistics study teams and across departments to produce deliverables of the highest quality possible, within agreed timelines and budget, and in conformance with applicable International Council for Harmonization (ICH) guidelines, Pharmaceutical Industry standards and guidelines, Regulatory Authority requirements and guidelines, and Innovaderm’ standard operating procedures (SOPs) and processes.

More specifically, the Biostatistician must:

- Adhere and promote company organizational values and related expected behaviors, follow company SOPs and processes for all deliverables, and ensure all trainings assigned to oneself are completed on time.

- Act as Lead Biostatistician on multiple Phase 1 to 4 clinical trials by:

- Acting as Biostatistics primary point of contact for Leads from other Innovaderm departments, Sponsors, and 3rd party vendors for clinical trials.

- Be responsible for all statistical aspects of clinical trials.

- Supporting teams of Statistical Programmers performing statistical analyses of clinical trials data.

- Managing timelines of the deliverables of Biostatistics study teams for clinical trials.

- Reviewing the scope of work and budget for Biostatistics study teams at initiation of clinical trials.

- Proactively and promptly identifying out of scope (OoS) works throughout the course of clinical trials, providing Project Managers with budget estimate, and making sure that these OoS budgets are properly included in Change Orders (COs).

- Ensuring that the forecast of Biostatistics study teams’ budget is accurate at all times, performing revenue recognition of Biostatistics budgets monthly, and monitoring monthly, project-to-date, and overall HPIs of clinical trials.

- Review and provide input into statistical sections of protocols (incl., sample size calculations or validation) to ensure statistical designs and planned statistical analyses clearly and robustly address the objectives of clinical trials and program of studies.

- Participate to the development of Risk-based Monitoring Plan for clinical trials by ensuring that appropriate critical data are taken into consideration when developing this plan and appropriate monitoring strategy are selected for each of these critical data.

- Review and provide input into various DM documents (e.g., electronic Case Report Forms [eCRF], Data Validation Specifications [DVS], Data Transfer Agreements [DTAs], etc.) for clinical trials and support DM with data cleaning activities by programming, reporting, reviewing, and closing biostatistical data issues in collaboration with Statistical Programmers.

- Develop Unblinding Plans, SAPs, and TLF Shells for clinical trials.

- Perform (Lead) Biostatistician review of Clinical Data Interchange Standards Consortium (CDISC) Standard Data Tabulation Model (SDTM) trial domains, subsets of Analysis Data Model (ADaM) datasets (e.g., ADSL, efficacy, ADaMs with complex derivations, etc.) or derived datasets (as applicable), and all TLFs of clinical trials based on the protocol, SAP, TLF Shells, and Innovaderm and/or Sponsor' standards and interpretation of CDISC SDTM Implementation Guideline (IG), ADaM IG, and Controlled Terminology (CT).

- Review and provide input into statistical sections of CSRs to ensure results from statistical analyses are co