Innovation and Experimentation Lead within Data Assets Framework and Services group in Biostatistics. Constructs frameworks and ways of working maximizing the value from re-use of completed clinical trial data. Accountable for modernizing the designing of data process, transformation, integration & framework with a focus on promoting and instilling FAIR data principles.

Programming Leader in Technical Excellence and Innovation department in Clinical Programming (Biostatistics). Tech Lead on transformational Clinical Linked Data initiative utilizing graph database to facilitate automation in clinical reporting.

- Designing, prototyping and building advanced analytic engines and services- Working as part of an agile team at the interface with business experts, interacting with teams within R&D to gather business/process knowledge- Translating R&D business problems into computational problems to enable data-driven decisions- Setting-up projects and steering external partners in implementing data catalogues, data models, predictive models and interfaces supporting data access, analysis and visualization- Aligning with IT department regarding integration of such interfaces into Grünenthal system landscape

Designing, developing, documenting, validating and maintaining SAS programs to derive, store, analyze and report clinical data. Developing, applying and maintaining standard SAS programs and macros including metadata-driven programming approach. Performing data pooling and data mapping. Supporting adhoc analyses and developing data visualization scripts. Collaborating with data science internal and external partners in all activities where handling and programming of clinical data is required (e.g. establishing CROs contracts and specifications, collaborating in identification of protocol deviations, actively reviewing SAPs, Shell TFLs, CRFs, data validation plans etc., collaborating with Medical Affairs, Market Access, Translational Science departments to address their questions to clinical data, claims data and beyond). Reviewing the project management plan of the trials, on an ongoing basis, to check if the deadlines are met. Cooperating with Clinical Research Organizations. Defining, implementing and maintaining data standards (SDTM, ADaM) and SAS dataset structures. Assisting in maintenance of a Clinical Data Repository. Looking for opportunities for applying innovative programming methods to research and development of new drugs. Working according to ICH-GCP and ICH-biostatistics guidelines as well as the internal quality system.

Ensuring successful delivery of the direct report’s project deliverables, on time with high quality. Mentoring junior staff. Managing and overseeing team activities including appropriate resourcing, staff assignments and quality control of project deliverables. Monitoring performance. Providing technical support to team members to ensure that they have the required knowledge to fulfill their duties. Recruiting, retaining and developing a skilled, experienced and motivated team. Maintaining the agreed level of productivity/billability and staff turnover. Providing consultation, facilitating metrics collection and develop action plans in conjunction with Management/Project Leadership/Leads to keep projects on time and within budget. Serving as an ongoing liaison with Project Team, Sponsor and management regarding performance of direct reports. Participating in formal staff review processes e.g. performance and compensation reviews to corporate standards and timescales. Maintaining a working knowledge of, and assuring compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and PAREXEL SOPs. Participating in PAREXEL and department system/standards improvement activities. Completing routine administrative tasks in a timely manner (e.g. timesheets, metrics).

Fulfilling a programming lead role within a designated project team. Interaction with clients as a direct contact with regards to statistical programming issues. Monitor quality, timelines, resource allocation, and productivity in relation to budgets. Production and QC of tables, figures, appendixes, patient profiles, data listings, derived data sets and data set specifications including pooled datasets. Involvement in recruiting process, interviewing candidates for Statistical Programming roles. Managing and overseeing team activities including appropriate resourcing of staff, staff assignments and quality control of project deliverables.

Production and quality control of derived datasets and statistical outputs of all complexities. Interaction with internal and client’s biostatisticians, discussion of SAP and specifications issues. Providing basic statistical advice. Fulfilling project primary role within a designated project team.

Production and QC of tables, figures, derived datasets and data listings of any complexity using efficient programming techniques. Analysis dataset specifications development. Interaction with internal and client’s biostatisticians. Discussion of SAP and specifications issues.

Production of tables, figures, derived datasets and data listings using efficient programming techniques. Analysis dataset specifications development. Programming of not implemented in SAS statistical methods such as Dunnet-Tamhane step-up procedure.