Biostatistical Programming Manager

What you will do

In this vital role you will be responsible for manipulating large databases and generating reports to partner with epidemiologists to explore and generate RWE from real-world healthcare data assets. The ideal candidate should possess a bachelors degree and have at least six years of relevant career experience in statistical programming. Proficiency in SQL programming and SAS or R programming is required. The successful candidate will demonstrate scientific and technical excellence, exceptional oral and written communication skills, problem-solving abilities, and meticulous attention to detail. The ability to work effectively within a large, globally distributed team is essential.

Responsibilities:

• 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
• Masters degree and 4 to 6 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience OR
• Bachelors 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.