Senior Statistical Programmer SDTM

Cytel

Germany

Summary of Job Responsibilities:

As member of the Project Based Services (PBS) department, and reporting to the Global Head of Statistical Programming or to the local manager (Director statistical programming or Associate director of statistical programming), the main responsibilities of the Senior Statistical Programmer will be to:

Lead, or contribute to, statistical programming activities on PBS projects, specifically DMC projects (development or QC of deliverables):
- delivering exemplary performance and solving complex technical problems to inspire other programmers;
- ensuring an efficient collaboration with PBS global teams (Europe, India, and US);
- being accountable for the quality, traceability, reproducibility and timeliness of statistical programming deliverables;
- being accountable for overall client satisfaction with these deliverables;
- maintaining a detailed project and validation plan;
- efficiently communicating with internal and external clients;
- ensuring budget monitoring and adherence;
- multitasking on multiple deliverables at any given time in different stages of production or QC;
- meeting tight, often changing timelines.
Ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements, for instance:
- Clinical study reporting, e.g. ICH E3;
- Electronic records handling, e.g. Chapter 21 of the US Code of Federal Regulation - Part 11;
- Electronic submission of clinical data to agencies, e.g. e-CTD guidance and CDISC SDTM and ADaM standards.
Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers…);
Understand, follow and ensure adherence to all BDM SOP as well as any other relevant SOPs;
Keep abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementation.

Occasionally, responsibilities will also include to:

Lead, or contribute to, the design of new statistical programming processes or optimization of existing ones to reach the best productivity, to ensure the best quality of the statistical outputs, and to reach the best customer satisfaction (internally and externally) with flexibility, reliability and responsiveness.

Qualifications and Experience:

BSc or equivalent with research experience, and/or MS (in a numerate discipline preferably in Statistics, Computer Science, or Mathematics);
8+ years of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development, with 2+ years of CRO experience;
Experience as a lead statistical programmer on several concurrent projects;
Ability to transition between multiple deliverables within the same week or even day. Multitasking and organization is a must;
Experience with programming on dirty data or limited patient size;
Experience with iterative reporting;
Experience reading, running, and updating SAS programs written by others;
Experience with specifying and programming ADAM-like datasets from raw CRF data;
Experience with tight, often changing, timelines;
Strong SAS programming skills;
Strong CDISC ADaM and SDTM- production/validation or ADaM-like datasets;
Good understanding of drug development, including knowledge of interfaces and interdependencies with other functions;
Project management skills;
Fluent in English (French and/or German is a plus);
Ability to work effectively in international teams, effectively operates within a matrix organization and with multi-disciplinary groups, excellent team player with strong interpersonal skills contributing to building the team spirit;
Ability to rapidly understand and anticipate the needs of internal and external customers, and respond to their inquiries;
Good negotiation and issue resolution skills;
Ability to educate internal and external interfaces (providers and customers) on the statistical programming processes, and the underlying regulatory requirements;
Mentoring skills.