Prinicipal Statistical Programmer

I am recruiting for a Statistical Programmer for a multinational pharmaceutical, they are a European leader and one of the largest globally in their field.

Statistical Programmer

The role: Provides statistical programming support to all Grifols clinical trials and supervises the statistical programming activities performed internally and externally. Provides guidance to the clinical development department in the direction of clinical data standards for Grifols statistical tables, listing, and figures that satisfy requirements for regulatory submissions of Clinical Study Reports and New licence applications of clinical data. Provides data outputs on ongoing trials for investigator brochures, data safety reports etc.

Location: Remote working in Republic of Ireland

Salary: Excellent salary, bonus and benefits available. Contact John Finn for more information.

Key Responsibilities:
* Manages and coordinates the programming activities in clinical trials to ensure the timely completion and required standards of quality of analyses providing results and their presentation.
* Generates and validates statistical analyses (tables, listings and figures) using SAS and other software. Assists in the development of data analysis plans, coordinates programming and data management when work is outsourced to vendors. Reviews the statistical/programming deliverables, ensures standards and work conducted according to regulatory and SOPs.
* Reviews programming and a variety of data management related document including case report form design, annotation of case report forms, edit checks and database structure.
* Interacts regularly with other team members within clinical development and or in other departments (ie Pharmacovigalence) and participates as an integral member of the clinical project team. Supports reconciliation between of clinical data residing in the clinical database versus the pharmacovigalence data base that houses serious adverse events.
* Performs validation and quality checks on deliverables produced internally and or via external vendors.
* Supports Regulatory Affaires with electronic submission of data to FDA/EMEA and other regulatory bodies by preparing outputs under CRT folder meeting compliance of eCTD guidelines.
* Draft SDTM/ADAM data specifications on an as-needed basis.
* Manages the programming work outsourced to CRO.

Your knowledge and experience:
* Good knowledge of medical and statistical terminology. Good programming skills in SAS, including SAS macro language, data manipulation techniques, data reporting procedures (PROC REPORT, ODS, SAS/Graph), and statistical procedures (e.g., PROC FREQ, PROC UNIVARIATE, PROC SUMMARY, PROC MEANS). Strong organisation, analytical, verbal and written communication skills. Ability to multitask and prioritise work. Ability to implement the regulatory standards in clinical data base and clinical data tabulation.
* Working knowledge of ADaM and SDTM data standards and data structures.
* Bachelor's of Science in statistics or related field. Typically requires 2-5 years of experience in programming and analysing the clinical trial data in clinical research organisation (CRO), pharmaceutical, or biotechnology industries.

If you are interested in this Statistical Programmer position, please contact me through LinkedIn or directly to arrange a confidential follow up call: 01 645 5222, Mobile: 087 621 4254, [email protected]