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 correctly reported and interpreted.
- Act as Unblinded Support Biostatistician for clinical trials by reviewing Randomization Plans, Dummy Randomization Lists, and Final Randomization Lists developed by the Unblinded Biostatistician.
- Conduct statistical analysis for Investigator Initiated Studies (IISs) and internal research and development (R&D) projects.
- Contribute to the identification of future internal initiatives to increase efficiency/quality of Biostatistics activities/deliverables and participate to the conduct of such internal initiatives.
- Keep oneself abreast with latest Industry and CDISC standards as well as ICH and Regulatory Authority guidance and requirements.
May also:
- Contribute to the development/maintenance/validation of the statistical programming of ADAMs and TFLs for clinical trials.
- Act as Unblinded Biostatistician by developing or reviewing Randomization Plans, Dummy Randomization Lists, and Final Randomization Lists for clinical trials as well as by leading Unblinded Biostatistics teams and supporting Independent Data Monitoring Committees (IDMCs) for Interim Analyses (IAs).
- Attend meetings outside of employee’s normal business hours.
- Act as a Peer Biostatistician on multiple clinical trials.
- Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.
Requirements
- Master’s degree or PhD in Statistics, Biostatistics, or a related field with some applied biostatistics trainings relevant to clinical trials required.
- At least 1 year of clinical trials experience in the Biotechnology, Pharmaceutical, and/or Contract Research Organization (CRO) industries required.
- Good knowledge of drug development process, ICH guideline (including but not limited to, ICH E6(R2), E9, and E9(R1)), and relevant Health Canada (HC) and Food and Drug Administration (FDA) regulations and guidelines preferred.
- Significant exposure to clinical trial data, SAPs, and TLF Shells preferred.
- Good knowledge of CDISC standards and guideline an asset.
- Good working knowledge of SAS for the purpose of analyzing clinical trial data preferred.
- Very organized and detail-oriented, with effective project planning and time management skills.
- Ability to work in high-speed environment with proven agility to juggle and prioritize multiple competitive demands.
- Must be able to work independently and as part of a team.
- Strong verbal and written communication skills in English; French an asset.
Our company
At Indero, formely Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
As a Biostatistician, you will be eligible for the following perks:
- Permanent full-time position
- Flexible schedule
- Home-based position
- Ongoing learning and development
Work location
The successful candidate for this position is given to work remotely anywhere in Romania
About Indero, formely Innovaderm
Indero, formely Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero, formely Innovaderm continues to grow and expand in North America and Europe.
Indero, formely Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero, formely Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Indero, formely Innovaderm only accepts applicants who can legally work in Romania
Description de poste
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Profil recherché
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Notre entreprise
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