Job Title Senior Statistical Programmer
Department Global Data Operations
The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, might
act as an internal subject matter expert in specific areas providing technical support and expert advice,
and works independently to support various programming activities related to the analysis and
reporting of clinical study data. In addition, the Senior Statistical Programmer can fill the Statistical
Programming Coordinator role on projects, and liaise with sponsors, Data Operations Leads, and other
functional areas as required.
Reports To Associate Manager, Manager or Senior Manager
Directly Supervises N / A
Provides Work Direction to Statistical Programmer I; Statistical Programmer II; Senior Statistical
Programmer; Principal Statistical Programmer; Other members of the
Statistical Programming department as appropriate
Works Closely with Biostatisticians, Database Programmers, Data Operations Lead,
QMG, Clinical Data Analysts, GRO Lead, RRC, Medical Writing, IT,
Proposals and Business Development
External Relationships Sponsors, Third Party Vendors, Auditors
Deliver best value and high quality service
Ability to fill Statistical Programming Coordinator role on projects. The Statistical Programming
Coordinator will :
o Input into and negotiate statistical programming timelines. Ensure that timelines are
o Coordinate and lead a statistical programming team to successful completion of a study
within given timelines and budget
o Monitor project resourcing, project budgets, and identify changes in scope
Interact with Sponsors as the key contact with regard to statistical programming issues
Provide technical support and advice to the internal team
Check own work in an ongoing way to ensure first-time quality
Ensure quality control (QC) on all process and technical activities related to derived dataset, table,
listing, and figure programming in accordance with corporate quality standards,
WSOPs / Guidelines, ICH-GCP and / or other international regulatory requirements are performed.
Coordinate project start-up activities, including Unix / PMED project area set-up, creation of global
programs (e.g., setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation.
Assist in the production and QC of analysis plans, produce and QC TLF mock-shells, derived
dataset specifications, programming specifications, and other process supporting documents.
Use efficient programming techniques to produce and / or QC derived datasets tables, figures and
Understand regulatory requirements concerning industry technical standards (e.g., CDISC, 21 CFR
Part 11, electronic submissions, etc.) and implications for the department.
Provide input into monthly PERFORM forecasts and monitor the completion of forecasted units.
Create standard macros and applications to improve the efficiency of the department.
Maintain all supporting documentation for studies in accordance with WSOPs / Guidelines to
ensure traceability and regulatory compliance
Be trained in sponsor WSOPs and disseminate knowledge to project team members as
Proactively participate in and / or lead process / quality improvement initiatives
Work closely with the Quality Management Groups (QMG) to ensure compliance with
WSOPs / Guidelines, ICH-GCP and any other applicable local and international regulations and
participate in internal / external audits and regulatory inspections as required
Develop wider knowledge of SAS and other relevant programming languages and processes
within the GRO, Biostatistics, and Medical arenas.
Maintain and expand local and international regulatory knowledge within the clinical industry
Assist project teams in the resolution of problems encountered in the conduct of their daily work
Provide relevant training and mentorship to staff and project teams
Proficiency in SAS
Knowledge of the programming and reporting process
Knowledge of WSOPs / Guidelines / System Life Cycle methodologies, ICH-GCP and any other
applicable local and international regulations such as 21 CFR Part 11 and proven practical
Demonstrate ability to learn new systems and function in an evolving technical environment.
Strong leadership ability
Attention to detail
Ability to successfully work together with a (virtual) team (including international teams as
required) as well as independently
Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to
Business / Operational skills that include customer focus, commitment to quality management and
Good business awareness / business development skills (including financial awareness)
Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.
Work effectively in a quality-focused environment
Demonstrate commitment to refine quality processes
Effective time management in order to meet daily metrics or team objectives
Show commitment to and perform consistently high quality work
Educated to degree level in a relevant discipline and / or equivalent work experience
Competent in written and oral English.
Excellent communication skills.
Minimum Work Experience
Relevant Clinical Trial industry experience