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    Senior Statistical Programmer (Poland)

    Innovaderm Research
    7+ years
    Not Disclosed
    Poland
    10 Nov. 24, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences/ B.sc/ IT/ B.tech/B.ca 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

    Senior Statistical Programmer - Innovaderm (Remote, Poland)

    Overview
    The Senior Statistical Programmer at Innovaderm will lead multiple clinical trials, managing the development, maintenance, and validation of annotated Case Report Forms (aCRFs), SDTM datasets, ADaM datasets, and Tables, Listings, and Figures (TLFs). The role will involve collaborating with biostatistical teams, supporting data cleaning, and ensuring compliance with industry standards, such as CDISC, ICH, and regulatory requirements. The Senior Statistical Programmer will also work to improve internal processes and increase efficiency in statistical programming activities.

    Responsibilities

    Programming and Data Management

    • Lead programming efforts on multiple clinical trials, ensuring timely and high-quality deliverables.
    • Review the statistical programming scope and budget at the initiation of trials to identify out-of-scope tasks.
    • Support Data Management (DM) teams with data cleaning activities, including programming and closing statistical data issues.
    • Develop, maintain, and validate (as needed) aCRFs and statistical programming specifications for SDTMs, ADaMs, and TLFs.
    • Ensure SDTMs, ADaMs, and define.XMLs comply with CDISC guidelines and Innovaderm/Sponsor standards.
    • Use Pinnacle 21 to validate SDTMs, ADaMs, and define.XMLs, addressing any findings with the Statistical Programmer or Lead Biostatistician.
    • Create and maintain global SAS macros to increase programming efficiency for SDTMs, ADaMs, and TLFs.
    • Act as the Unblinded Primary or QC Statistical Programmer for randomization plans, interim analyses (IAs), and Data Monitoring Committee (DMC) data reviews.

    Quality and Process Improvement

    • Identify and contribute to internal initiatives to improve efficiency and quality in statistical programming, such as the development and validation of standard macros and templates.
    • Stay updated with the latest industry standards, including ICH, CDISC, and regulatory authority guidelines.
    • Mentor junior Statistical Programmers and provide guidance on best practices and industry standards.

    Collaboration and Communication

    • Collaborate with biostatistical study teams and cross-functional departments to produce deliverables within timelines and budgets.
    • Communicate effectively with internal and external stakeholders, including the Sponsor, to ensure alignment on project goals and timelines.
    • Participate in internal initiatives and contribute to improving the statistical programming processes.

    Requirements

    Education

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

    Experience

    • At least 7 years of experience in clinical research within the biotechnology, pharmaceutical, or CRO industry.
    • Minimum of 5 years in Statistical Programming, with at least 2 years as a Lead Statistical Programmer.

    Skills and Knowledge

    • Strong knowledge of clinical trial data, SAPs, TLF Shells, and specifications.
    • Excellent working knowledge of SAS; SAS certification is an asset.
    • Proficiency in XML programming is a plus.
    • Familiarity with CDISC standards and guidelines; CDISC certification is an asset.
    • Knowledge of drug development processes and ICH guidelines (including E6, E9, E9(R1)) as well as relevant Health Canada and FDA regulations.
    • Strong organizational skills, with the ability to manage multiple projects in a fast-paced environment.
    • Ability to work independently and in team settings, with strong communication skills (verbal and written) in English.

    Why Innovaderm?

    Work Environment
    At Innovaderm, you'll join a collaborative and innovative team. We value reliability, responsiveness, and continuous improvement. The company offers a dynamic and supportive work environment, as well as ample opportunities for professional growth.

    Benefits

    • Permanent, full-time position.
    • Flexible work schedule and home-based role.
    • Ongoing learning and development opportunities.
    • Competitive compensation and vacation benefits.

    Work Location

    This role is remote-based within Poland. As the company operates across multiple time zones, flexibility in working hours is required to accommodate global team and client meetings.

    About Innovaderm

    Innovaderm is a Contract Research Organization (CRO) specializing in dermatology. With a solid reputation for excellence, Innovaderm has been providing high-quality research and services to exceed client expectations since 2000. Headquartered in Montreal, Innovaderm continues to expand its footprint in North America and Europe.

    Commitment to Equity
    Innovaderm is committed to providing equitable treatment and equal opportunities for all individuals. We provide accommodations throughout the recruitment process for applicants with disabilities upon request.

    Note
    Innovaderm only accepts applicants who are legally eligible to work in Poland.

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