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    Principal Programmer Analyst (Bios)

    Thermo Fisher Scientific
    7+ years
    Not Disclosed
    Remote
    10 Sept. 11, 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

    Work Schedule:
    Standard, Monday to Friday

    Environmental Conditions:
    Office-based

    Job Description:

    Position Overview:
    Serve as the lead programmer or project lead overseeing the statistical and bioinformatics programming aspects of clinical trials from design through analysis and reporting. Act in a project oversight role when required, manage teams to implement study strategies, ensure programming efficiencies, and handle the creation and maintenance of standard programs for statistical report generation and validation. Represent the department internally and with clients and regulatory agencies, contributing to or leading proposals and bids. Provide training, guidance, and leadership to junior team members.

    Essential Functions:

    1. Lead Role: Act as the lead programmer or project lead on studies and drug programs of varying complexity, including NDA submissions. Collaborate with project team leaders and client representatives to conduct team meetings, oversee project timelines, forecast resource needs, and manage study budgets while adhering to contractual obligations with clients.
    2. Contract Modifications: Lead discussions regarding contract modifications with clients as necessary.
    3. Process Improvement: Identify, plan, and implement tool and process improvements to enhance efficiency. Collaborate with senior management to lead process or tool enhancement initiatives.
    4. Project Management: May serve as the company project manager for biometrics services projects.
    5. Project Oversight: May take on a project oversight role for selected projects, including NDAs.
    6. Regulatory Submissions: Contribute to or review key submission materials for regulatory authorities.
    7. Department Support: Provide general support to the department by representing the company at industry conferences, presenting and teaching at departmental meetings, assisting with training materials, contributing to departmental documents or policies, and participating in process improvement initiatives.
    8. Professional Development: Enhance knowledge and skills for yourself and junior team members in areas such as programming technology, clinical trials, and pharmaceutical industry developments.
    9. Performance Feedback: Provide feedback to managers on employee performance for development, performance reviews, and training purposes.
    10. Industry Promotion: Promote and enhance the company's visibility in the industry through presentations at conferences and chairing industry sessions.

    Education and Experience:

    • Required: MS/MA degree in Computer Science, Statistics, Biostatistics, Mathematics, or a related field with at least 7 years of relevant experience.
    • Alternative: Bachelor's degree in Computer Science, Statistics, Biostatistics, Mathematics, or a related field with at least 9 years of relevant experience.

    Knowledge, Skills, and Abilities:

    • Proficient in SAS® programming.
    • Mastery of database structures and complex data management.
    • Excellent attention to detail and problem-solving skills.
    • Strong written and verbal communication skills, with proficiency in English.
    • Ability to independently organize, adapt to changing priorities, and manage multiple assignments.
    • Experience leading and working in a multidisciplinary team setting.
    • Positive attitude with strong teamwork and mentoring capabilities.
    • Deep understanding of clinical trials, ICH Statistical and reporting guidelines, and GCP.
    • Exceptional knowledge of statistical principles applied to clinical trial design and analysis.
    • Knowledge of regulatory submission requirements for clinical data.
    • Excellent project management skills, including budget creation, modification, and risk management.
    • Ability to interpret and contribute to company policies.
    • Commitment to high-quality delivery and drive for excellence.

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