Dear All,
I am currently searching for a Statistical Programmer to join a market leading pharmaceutical company in Germany, on a permanent bases. Please find below the job spec for this position.
Overview
The Statistical Programmer will support worldwide statistical programming activities for assigned project area within this organisation, for clinical trials whose responsibility resides in Development; Function as trial lead programmer, or trial programmer with respect to all programming activities. Set-up and oversee trial, and provide programming support to enable team deliverables. Generate datasets and tables, figures, listings for clinical study reports, ad hoc requests, and submissions; Produce submission ready electronic deliverables and documentation that support and match project deliverables and are sufficient to respond quickly to questions by regulatory authorities; Interface with project teams and Health Outcomes functional group; and Ensure respect to agreed deadlines.
Major Accountabilities:
• Lead and support programming of trials assigned to own statistical programming operations team and support the global team of Statistical Programmers. Provide input for assigned projects and trial teams.
• Develop a good collaboration with departments within Global Data Operations, and outside Global Data Operations (Global Biostatistics, Global Health Outcomes Research, Global Medical Writing, New Medicines, Global Clinical Operations, Therapeutic Areas, Global Medical Affairs and Affiliates).
• Program, validate, maintain, and document statistical analysis programs for clinical trials on the basis of the Statistical Analysis Plan and of other trial documents (Protocol, CRF, DMM) following standard operating procedures and working documents.
• Ensure that submission and trial datasets, tables, figures, listings, and statistical outputs meet standards requirements of regulatory agencies and other departments
• Ensure that datasets, tables, figures, listings, and statistical outputs are produced in an efficient manner, following standards where applicable. Assist with developing standard specifications of analysis datasets, pooled datasets, tables, figures, listings, and data structures.
• Support direction, motivation, and oversight of statistical programming resources (internal and external) for timely delivery of all statistical programming deliverables. Mentor other statistical programmers as designated.
• Support development and rollout of new standards and processes with respect to own statistical programming operations team.
• Ensure compliance with the 21-CFR Part 11 regulations in terms of validation of SAS programs used for the purpose of statistical reporting of clinical studies.
• Such other responsibilities and projects that the Company may assign.
Qualifications
Education: Bachelor's Degree Required
Experience:
• At least 3 years in Statistical Programming within the Pharmaceutical Industry.
Specific Skills:
• Intermediate SAS skills.
• Good communication skills to report activities, results, and processes to Managers, Heads and Directors of this company
• Command, both verbal and written, of English.
• Emerging leadership skills to obtain action, consent, agreement or approval, when necessary
• Ability to obtain co-operation within team environments in an effort to facilitate open communication and team effectiveness.
• Emerging project management skills.
• Independent decision making and implementation.
Problem Solving:
• Good analytical ability, exhibiting characteristics that are structured and methodical to ensure that sound, decisions are made.
• Able to use facts, data, measurements and to have a systematic approach.
• Able to plan, perform, trouble-shoot and make decisions based on precedent, company policies, procedures, international and national regulations and Good Clinical Practice. All decisions must be weighed for strategic implications in all Global Data Operations departments and other Development Departments.
• Judgement to work accurately and efficiently toward quality results and to create new processes and procedures, when necessary.
• Proactive in evaluating trial and project reports to detect problematic issues.
If you are interested please contact Hannah Edmonds via [log in to unmask] or +44 (0) 1273 727930.
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