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Lead statistical Programmer

Karwell Technologies

  • Boston, MA
  • 30+ days ago
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    Skills

    • Analysis Skillsunmatched
    • Best Practicesunmatched
    • Biostatisticsunmatched
    • Biotech and Pharmaceuticalunmatched
    • Case Report Form (CRF)unmatched
    • Clinical Dataunmatched
    • Clinical Data Interchange Standards Consortium (CDISC)unmatched
    • Clinical Practices/Protocolsunmatched
    • Clinical Supportunmatched
    • Clinical Trialunmatched
    • Code Reviewsunmatched
    • Communication Skillsunmatched
    • Computer Programmingunmatched
    • Computer Scienceunmatched
    • Contract Requirementsunmatched
    • Contract Research Organization (CRO)unmatched
    • Corrective Actionunmatched
    • Customer Relationsunmatched
    • Data Managementunmatched
    • Data Setsunmatched
    • Database Designunmatched
    • Database Programmingunmatched
    • Debugging Skillsunmatched
    • Detail Orientedunmatched
    • Documentationunmatched
    • Drug Developmentunmatched
    • Industry Standardsunmatched
    • Interpersonal Skillsunmatched
    • Leadershipunmatched
    • Mathematicsunmatched
    • Medical Writingunmatched
    • Multitaskingunmatched
    • Organizational Skillsunmatched
    • Pharmacovigilanceunmatched
    • Pinnacleunmatched
    • Presentation/Verbal Skillsunmatched
    • Problem Solving Skillsunmatched
    • Process Improvementunmatched
    • Program Planningunmatched
    • Project Developmentunmatched
    • Project Planningunmatched
    • Project/Program Managementunmatched
    • Quality Metricsunmatched
    • Regulationsunmatched
    • Regulatory Requirementsunmatched
    • Regulatory Submissionsunmatched
    • Risk Analysisunmatched
    • Risk Managementunmatched
    • SAPunmatched
    • SQL (Structured Query Language)unmatched
    • Software Administrationunmatched
    • Software Engineeringunmatched
    • Statistical Analysis System (SAS)unmatched
    • Statistical Programming Languagesunmatched
    • Statisticsunmatched
    • Strategic Planningunmatched
    • Team Playerunmatched
    • Technical Leadershipunmatched
    • Time Managementunmatched
    • Traceabilityunmatched
    • Training/Teachingunmatched
    • Writing Skillsunmatched

    Description

    Job Summary:
    The Contract Lead Programmer serves as a senior, hands-on programmer responsible for managing statistical programming activities across multiple clinical trials and therapeutic areas. The role oversees external CRO partners to ensure high-quality, timely, and compliant delivery of analysis datasets, tables, listings, and figures that support clinical development and regulatory submissions. The position involves hands-on technical leadership and requires comprehensive and detailed knowledge of statistical programming languages and software, filing support, clinical trial databases, and the drug development process.
    Responsibilities:
    • Lead statistical programming activities and deliverables (e.g., SDTM/ADaM datasets, tables, listings, figures, review esub data packages with Pinnacle 21) across multiple studies and programs, serving as the primary programming point of contact. Must be able to review TMF for programming deliverables, including SAP.
    • Oversee CRO programming activities by reviewing programming plans, SDTM/ADaM specifications, TLF shells, validation strategies, and issue logs.
    • Monitor internal and CRO delivery against timelines, quality metrics, and contractual obligations; identify risks and implement mitigation or corrective actions as needed.
    • Ensure consistency of standards, templates, macros, and processes across internal and external teams, and drive adoption of programming best practices.
    • Provide hands-on programming support to complex or high-priority analyses, ad-hoc requests, and regulatory responses, as needed.
    • Partner with biostatistics to design, implement, and maintain programming development plans for each project, ensuring timely and high-quality deliverables aligned with internal and industry standards.
    • Partner with data management to apply CDISC standards during CRF design and database development.
    • Partner with biostatistics, data management, clinical, regulatory, pharmacovigilance, and project management to align programming strategies with study-level plans and regulatory expectations.
    • Collaborate with medical writing, clinical, and regulatory on study-level initiatives.
    • Support inspection and audit readiness by ensuring appropriate documentation, traceability, and reproducibility of programming deliverables from both internal and CRO teams.
    Requirements:
    • Master's degree (or equivalent experience) in statistics, computer science, mathematics, or a related field.
    • 10+ years of programming experience in the pharmaceutical, biotechnology, or CRO industry.
    • 3-5 years of experience as a lead programmer in statistical programming and CRO oversight.
    • Proven record in developing and implementing statistical programming standards and procedures.
    • In-depth knowledge of CDISC (CDASH, SDTM, ADaM) standards and regulatory submission requirements.
    • Advance proficiency in Base SAS, SAS/STAT, SAS Macro language, and SAS SQL; SAS/GRAPH a plus (SAS version 9 or higher).
    • Proficient in coding, debugging, and optimizing new and existing programs.
    • Experience leading studies and supporting NDA and EMEA submissions.
    • Adaptable, detail-oriented, effective under pressure with initiative to take on new challenges.
    • Demonstrated ability to establish and articulate a plan for a team to ensure appropriate focus and direction.
    • Excellent analytical, problem-solving, organizational, and multitasking abilities.
    • Excellent communication and interpersonal skills, both verbal and written.
    • Collaborative team player with a customer-focused mindset; strives to support others to succeed.
    • Ability to communicate technical information to non-scientists, and willingness to educate the internal team.
    • Committed to quality and maintaining a positive attitude under shifting priorities.
    • Ability to contribute to strategic planning for data standards, system infrastructure, and process optimization initiatives.

    Numbers & Facts

    LocationBoston, MA

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