Data Analysis jobs in Canada

The Statistical Programmer will be responsible for the development, maintenance, and validation of annotated Case Report Forms (aCRFs) as well as of specifications and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets (or derived datasets, as applicable), Tables, Listings, and Figures (TLFs), and submission packages required for various purposes including, but not limited to Data Monitoring Committee (DMC) data review meetings, Interim Analyses (IAs), and Clinical Study Reports (CSR). The Statistical Programmer will also support Data Management (DM) with data cleaning activities, use global SAS macros, participate in internal initiatives to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs, and use Pinnacle 21 to validate the SDTMs, ADaMs, and define.XMLs.

The Statistical Programmer will work collaboratively within Biostatistical 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 Indero’s standard operating procedures (SOPs) and processes.

• 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.
• Review the statistical programming scope of work and budget when assigned on clinical trials and proactively and promptly identify tasks that are out of scope (OoS) and inform Lead Biostatistician of these OoS tasks.
• Support DM with data cleaning activities by programming, reporting, reviewing, and closing statistical data issues in collaboration with other Statistical Programmers and Lead Biostatistician.
• Develop/maintain/validate (as applicable) annotated Case Report Forms (aCRFs), specifications and Primary or QC statistical programming (as applicable) of SDTMs, ADaMs (or derived datasets, as applicable), TLFs, SDTM/ADaM define.XMLs/.PDFs, clinical SDTM/ADaM Reviewer’s Guides (cSDRGs/ADRGs) based on protocol, electronic Case Report Forms (eCRF), SAP, TLF Shells, Indero and/or Sponsor's standards and interpretation of Clinical Data Interchange Standards Consortium (CDISC) SDTM/ADaM Implementation Guidelines (IGs)/Controlled Terminology (CT), Pinnacle 21, and address any findings appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable).
• Use global SAS macros to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs.
• Contribute to the identification of future internal initiatives to increase efficiency/quality of Statistical Programming activities/deliverables (including but not limited to, development/improvement/validation of standard macros, templates, and programming standards and processes) and participate in the realization of these internal initiatives.
• Keep oneself abreast with the latest Industry and CDISC standards as well as ICH and Regulatory Authority guidance and requirements.

• Review and provide input into various DM documents (e.g., electronic Case Report Forms [eCRF], edit checks, etc.), Statistical Analysis Plans (SAPs), and Table, Listing, and Figure (TLF) Shells.
• Act as a Lead Statistical Programmer on single studies.
• Act as Unblinded Primary or QC Statistical Programmer for Independent Data Monitoring Committees (IDMCs) and Interim Analyses (IAs).
• Coach more junior Statistical Programmers.

• Bachelor’s degree in Statistics, Computing Sciences or a related field; Master’s degree an asset.

• At least 1 year of clinical research experience in biotechnology, pharmaceutical or CRO industry, including 1 year of Statistical Programming.

• At least 1 year of clinical research experience in biotechnology, pharmaceutical or CRO industry, including 1 year of Statistical Programming.
• Significant exposure to clinical trial data, SAP, TLF Shells, and specifications.
• Excellent working knowledge of SAS; SAS certification an asset.
• Knowledge of XML programming an asset.
• Good knowledge of CDISC standards and guidelines; CDISC certification an asset.
• Good knowledge of the drug development process, ICH guidelines (including but not limited to, ICH E6, E9, and E9(R1)), relevant Health Canada (HC) and Food and Drug Administration (FDA) regulations, guidelines, and electronic data submission requirements, and Pharmaceutical Industry Good Programming Practices (GPP).
• Very organized and detail-oriented, with effective project planning and time management skills.
• Ability to work in a 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.

At Indero, 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.

• Flexible work schedule
• Permanent full-time position
• Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
• Offices near public transportation (Sherbrooke metro station or Saint-Laurent metro station)
• Possibility of working from home in accordance with company policies and public health directives
• Ongoing learning and development

A Global Clinical Leader In Dermatology!

Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.

Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at a global scale.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Canada.