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    Manager, Statistical Programming

    Innovaderm Research
    7+ years
    Not Disclosed
    Canada
    12 Nov. 24, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Manager, SAS Programming

    Overview
    The Manager, SAS Programming is responsible for overseeing and executing the activities of the SAS Programming team. This includes tasks required for Clinical Study Reports (CSRs), DSMBs, interim analyses, Statistical Analysis Plans (SAP), data tables, and charts. The role also covers CDISC SDTM programming activities, collaborating across departments to deliver high-quality results within set timelines and budgets. The Manager will ensure all tasks comply with regulatory requirements, industry standards, and Innovaderm SOPs, while meeting sponsor expectations.

    Responsibilities

    • Team Oversight: Provide direct management of SAS programming operations, including assigning work, overseeing performance, conducting reviews, and approving timesheets.
    • Training & Mentorship: Train and mentor SAS programmers on regulatory guidelines, programming practices, and systems.
    • Resource Allocation: Allocate resources effectively within the department to ensure project delivery.
    • Data Standards: Create Define XML, Define PDFs, and Reviewers Guides. Annotate CRFs in line with CDISC Implementation Guidelines for migration to SDTM.
    • SDTM Migration: Follow standard procedures for SDTM migration and create standardized data table templates in line with SDTM.
    • Specifications & SAS Code: Write program specifications with biostatisticians and translate them into SAS code for datasets, tables, listings, and figure outputs.
    • Documentation: Document all changes to SAS code, programs, and specifications for transparency and consistency.
    • SOP Development: Assist in developing and maintaining SOPs for data standards and improve productivity, quality, and cost-efficiency.

    Ideal Profile

    Education

    • Bachelor’s degree in a relevant field is required.
    • A Master's degree in Computer Science, IT Systems, Statistics, Engineering, or related fields is an asset.

    Experience

    • At least 7 years in clinical research within the biotechnology, pharmaceutical, or CRO industry, with 5 years of experience in SAS programming.
    • At least 1 year of supervisory or project team lead experience is preferred.

    Knowledge and Skills

    • Extensive knowledge of CDISC SDTM implementation guidelines and clinical trial data.
    • Familiarity with regulatory requirements and electronic data submission processes.
    • Knowledge of SAS, XML programming, and clinical trial database specifications.
    • Strong time management, organizational skills, and attention to detail.
    • Strong communication skills in both French and English.
    • Ability to work independently and in teams, managing multiple competing demands.
    • Knowledge of Good Clinical Practices (GCP) and applicable FDA and Health Canada regulations.
    • SAS certification or Advanced Programmer experience is an asset.

    Why Innovaderm?

    Work Environment and Benefits

    • Flexible work schedule
    • Permanent, full-time position
    • Complete benefits package (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, social activities)
    • Ongoing learning and development opportunities

    About Innovaderm

    Innovaderm is a leading Contract Research Organization (CRO) specializing in dermatology. Since 2000, Innovaderm has built a reputation for exceptional research quality, exceeding client expectations. The company is headquartered in Montreal and continues expanding its presence in North America and Europe.

    Commitment to Equity
    Innovaderm is committed to providing equitable treatment and equal opportunities. Accommodations are available during the recruitment process for applicants with disabilities, upon request.

    Note: Applicants must have the legal right to work in Canada.

    Recruitment Process

    The recruitment process for this position involves interviews with Innovaderm team members via Teams video conference.

     

     

     

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