Statistical Programmer

Job description

Job Description

The Statistical Programmer is providing support or is responsible for statistical programming aspects of study-level deliverables under guidance. The position is a key contributor with biostatistics in ensuring that pharmaceutical drug-development plans are executed efficiently with timely and high quality deliverables.Contibute to statistical programming activities as Statistical Programmer for 1-2 studies or development of macros.
2. Build and maintain effective working relationship with cross-functional team. 3. Help the trial programmer with review of eCRF, data structures and data review activities.
4. Comply with company, department and CDISC standards and processes, support the review programming specifications as part of the analysis plans.
5. Ensure timely and quality development and validation of datasets and outputs (datasets, tables, figures and listings) for study-documents according to specifications (as assigned)
6. Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.
7. Extend knowledge of programming software (e.g. SAS) as well as CDISC requirements (SDTM, ADaM, eCTD, Define.xml), attend functional meetings and trainings.

Desired profile

Minimum requirements

1. Quality and timeliness of statistical programming deliverables and contributions as assessed by the Lead/Trial Programmer and the operational manager.
2. Effectiveness of communication and team behaviors as assessed by the cross-functional team members.BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field Fluent English (oral and written).
1. Basic SAS experience within a Statistical Programming environment to develop and validate deliverables
2. Basic experience in contributing to statistical analysis plans and/or constructing technical programming specifications
3. Basic understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, ICH)
4. Basic communications and negotiation skills, ability to work well with others globally.
5. Ideally 1-3 years of work experience in a programming role preferably supporting clinical trials or at least initial work experience as intern (no work experience for MS Statistics/Computer Science graduates)