Biostatistical Programming Mgr - Hyderabad / Secunderabad, Telangana - Amgen Technology Private Limited

Description

• Provide technical solutions to programming problems within CfOR(Centre for Observational research).
• Lead and develop technical programming and process improvement initiatives within CfOR
• Represent the programming function and participate in multidisciplinary project team meetings
• Project manage programming activities, according to agreed resource and timeline plans
• Ensure programming activities adhere to departmental standards and SOPs
• Write and/or review and approve 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 execute department-, product- and protocol-level macros and utilities
• Oversee the work of outsourced resources assigned to projects
• 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
• Relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Doctorate degree OR
• Master s degree and 4 to 6 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience OR
• Bachelor s degree and 6 to 8 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience OR
• Diploma and 10 to 12 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience

Preferred Qualifications:

• Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources in statistical programming projects
• 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: SQL required; SAS or R required; 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 or R
• Required: SQL
• Preferred: Python
• 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
• [Required for Regulatory RWE role]: CDISC (SDTM, ADaM)
• Scientific / technical excellence
• Oral and written communication, documentation skills
• Leadership
• Innovation
• Teamwork
• Problem solving
• Attention to detail