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
