Statistical Programmer
2d ago


Job Title Senior Statistical Programmer

Department Global Data Operations

Essential Function

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

Key Accountabilities

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

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.,,, 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 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

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

Show commitment to and perform consistently high quality work


Educated to degree level in a relevant discipline and / or equivalent work experience

Language Skills

Competent in written and oral English.

Excellent communication skills.

Minimum Work Experience

Relevant Clinical Trial industry experience

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