Team Leader, Statistical Programming (Russia)
Multiple Locations: Ukraine • Saint Petersburg, St.-Petersburg, Russia
Requisition Number: 2883
Position Title: Team Leader, Statistical Programming
SUMMARY: Manages a statistical programming team, provides leadership of technical standards within the programming function, and leads continuous improvement in the programming function’s operating systems.
- Manage the programming resource for a designated set of projects, involving the planning and allocation of project work, raising and helping resolve resource issues for the statistical programming function.
- Proactively manage and develop the performance of statistical programmers through performance management, resource review and planning, capability, disciplinary, training & development to meet the needs of the business.
- Perform the lead programming role, responsible for planning and delivery of all study programming activities including programs for edit checks, 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.
- Manage identifying system and process improvements, and to develop and implement solutions to improve the efficiency and quality of clinical study data processing and reporting.
- Lead development and maintenance of in-house programming standards in line with the above quality standards and regulations.
- Provide support for the bidding process, including contribution to budget review, bid defence meetings and development of the budget algorithm for stats programming activities.
- Provide consultancy, mentoring and guidance to 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).
- Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
- The job holder must be computer literate and numerate with a proven ability to adapt to various computer systems
- The job holder should have well developed consultancy and facilitation skills together with key competencies in customer focus, delivering on commitments, building strong relationships, communicating and influencing, embracing innovation and change, building capability and participative leadership.
- Educated to degree level.
- The jobholder has advanced SAS programming skills with expert knowledge in SAS/Macro, Proc Tabulate, Proc Report and ODS.Good working knowledge in SAS/Graph, Proc SQL.
- Strength of knowledge across a range of data management (e.g. data validation, audit trails, laboratory data transfer and coding dictionaries, electronic data capture) and statistical (e.g. data restructuring, data summary, analysis and reporting) applications.
- Experienced in guiding/mentoring other programmers
Employment Type: Regular
Community / Marketing Title: Team Leader, Statistical Programming (Russia)
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: St. Petersburg, RU