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Biostatistical Programming Manager Job Opening In India, India – Now Hiring Confidential


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

Required Skill Profession

Life Scientists


  • Job Details

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Unlock Your Biostatistical Programming Potential: Insight & Career Growth Guide


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