Senior Statistical Programmer

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 adhered to.

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.

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

data listings.

 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 WSOP’s and disseminate knowledge to project team members as

appropriate.

 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.

 Lead and supervise and/or create, implement and execute import and export programs, in either

standard format, client specific format or CDISC compliant format depending on nature of

request.

 Develop mapping specifications for data exports in accordance with applicable standards.

QualificationsProficiency 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

application.

 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

change.

 Business/Operational skills that include customer focus, commitment to quality management and

problem solving.

 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.

 Shows commitment to and performs consistently high quality work.