Teamleader - Biostatistics Programming

Michael Bailey Associates
Apr 2012
This job posting expired on June 2, 2012.
Responsible for leading a team of Pharmacokinetics/Pharmacodynamics programming specialists. Responsibilities:
* Support for the groups Global Clinical Pharmacokinetics (PK) / Pharmacodynamics (PD) and Global Pharmacometrics (PMx) in accordance with company standards, GCP and ICH quality standards and regulations in the area of programming (SAS)
* Support of all clinical PK/PD and PMx analyses by delivering the respective PK/PD or NONMEM datasets across all therapeutic areas and phases of clinical development for clinical PK/PD and PMx groups in Germany, USA and Japan;
* Responsible to develop programming concepts to be used within global clinical PK/PD and/or global PMx
* Development of international processes in the area of PK/PD and NONMEM dataset programming
* Preparing outsourcing concepts for clinical PK/PD and NONMEM datasets
* Responsible for the interface to Global Data Management and Statistical Programming


Masters or doctoral degree in mathematics, information systems or information technology.

More than 5 years experience in dataset programming with SAS in clinical programs with expertise of clinical PK/PD and NONMEM structures, CDISC datasets and submission requirements.

Continuing education in GCP, ICH and regulatory guidances concerning clinical PK/PD and PMx analyses and analyses data structures.

Good organisational and managerial skills, problem-solving abilities as well as good interpersonal skills and excellent leadership competencies are mandatory.

Fluency in written and spoken English and German.

Michael Bailey International is acting as an Employment Agency in relation to this vacancy.