Worldwide Clinical Trials are looking for an experienced Statistical Programmer or Senior Statistical Programmer ideally based in Saint Petersburg Russia to perform the lead programming role, lead continuous improvement in the programming function’s operating systems and provide consultancy across the function.
RESPONSIBILITIES : Tasks may include but are not limited to :
Perform the lead programming role, responsible for planning and delivery of all study programming activities including programs for derived datasets, CDISC (SDTM and ADaM) datasets, tables, figures and listings and program validation.
Ensure the maintenance of documentation e.g. the description of programs and validation* Produce ad hoc data summaries when requested during the course of a trial.
Liaise with internal departments, sponsors and other third parties to ensure all delivery requirements fulfil client needs.
Extract information from the system during the course of a trial e.g. summaries, data listings, study data sets.
Provide project support to the statistics reporting process through the specification of tables, figures and listings shells, writing of derived dataset specifications and the formatting of report documents and tabulations.
Lead development and maintenance of in-house programming standards in line with the above quality standards and regulations.
Lead role in identifying system and process improvements, and to develop and implement solutions to improve the efficiency and quality of clinical study data processing and reporting.
Validate software, in the role of system owner or tester, and test SAS Macros, maintaining the required validation and testing documentation.
Provide consultancy to CDM, Programmers and Statisticians on programming and associated software support.* Maintain a high level of expertise in : SAS applications (e.
g. BASE, MACRO, GRAPH, ODS, SQL), other software applications (e.g. Excel, Visual Basic, Word) and regulatory standards in computer systems, systems validation, Good Clinical Practice, clinical / statistical reporting and regulatory submission requirements.
Assist with Quality Assurance and Audit requirements* Assist the Director of Biostatistics with all other aspects of the job as required* Perform all activities in compliance with WCT and agreed sponsor quality system standards, relevant GCP standards and specifically with FDA Quality System Regulation (including 21CFR Part 11).
OTHER SKILLS AND ABILITIES :
The job holder must be computer literate and numerate with a willingness to adapt to various computer systems* Hands-on expert level project statistical programmer experienced in providing programming leadership to projects.
Statistical programming skills and knowledge across a broad range of applications together with key competencies in customer focus, delivering on commitments, building strong relationships, communicating and influencing, and embracing innovation and change. REQUIREMENTS :
Educated to degree level.* The jobholder has advanced SAS programming skills with expert knowledge in SAS / Macro, Proc Report and ODS.
Good working knowledge in SAS / Graph, Proc SQL, SAS / STAT. #L1-JM1