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Biostatistical Programming Manager

Biostatistical Programming Manager

ConfidentialHyderabad / Secunderabad, Telangana
26 days ago
Job description
  • Lead and develop technical programming and process improvement initiatives within CfOR
  • Design data quality enhancements
  • Represent the programming function and participate in multidisciplinary project team meetings
  • Project manage all programming activities, according to agreed resource and timeline plans
  • Ensure all programming activities on the project adhere to departmental standards
  • Write and / or review and approve all programming plans
  • Write and / or review and approve analysis dataset specifications
  • Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, etc.
  • Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications
  • Write, test, validate and complete department-, product- and protocol-level macros and utilities
  • Be responsible for the work of outsourced resources assigned to project
  • Lead and / or participate in the development and review of CfOR Policies, SOPs and other controlled documents
  • Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings
  • Participate in the recruitment of programming staff
  • Actively participate in external professional organizations, conferences and / or meetings
  • Provide input to and participate in intra-departmental and CfOR meetings
  • Contribute to the continuous improvement of programming, CfOR, and Research and Development (R&D)
  • Manage staff performance and oversee staff assignments and utilization
  • Basic Qualifications :

    • Bachelors degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject.
    • At least 6-8 years of relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting
    • Preferred Qualifications :

    • Masters degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
    • Training or experience using the Observational Medical Outcomes Partnership (OMOP) common data model
    • Experience :

    • Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials
    • Team management
    • Global collaboration
    • Request fulfillment oversight, clarifying requirements, project tracking, project fulfillment, statistical programming, issue resolution, expert resource, results delivery
    • Statistical programming : SAS and SQL required; R and Python preferred
    • Experience working with real-world healthcare data (RWD) such as healthcare claims (MarketScan, Optum Clinformatics, Medicare) and EHR databases (Optum EHR PanTher, Flatiron, CPRD, MDV)
    • Key Competencies

    • Hands-on programming and lead role
    • Expert statistical programming knowledge using SAS or R
    • Required : SAS
    • Required : SQL
    • Required : Experience with data quality or data quality platforms (for example : Informatica, Ataccama)
    • Preferred : Python
    • Preferred : R
    • Excellent verbal and written communication skills in English
    • Ability to have efficient exchanges with colleagues across geographical locations
    • Agile project management
    • Real-world data (RWD) including insurance claims databases, electronic medical records and patient registries; for example, MarketScan, Optum, PharMetrics, Flatiron, Medicare
    • OMOP common data model
    • Drug development life cycle
    • Statistics and basic epidemiology : Incidence and prevalence
    • Scientific / technical excellence
    • Oral and written communication, documentation skills
    • Leadership
    • Innovation
    • Teamwork
    • Problem solving
    • Attention to detail
    • Skills Required

      Data Quality, Sas, Programming, Sql

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    Manager • Hyderabad / Secunderabad, Telangana

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