Beschreibung
Job Description:- The Biostatistician is responsible for all statistical tasks outsourced to external service providers or performed in-house for all pre-clinical and clinical trials within the assigned clinical program. For example, clinical trial design/planning, regulatory interactions, analysis plan, reporting activities, CTD and summary documents, exploratory analyses, and statistical consultation of late-phase programs.
- Develop study designs and statistically relevant parts of Phase I, III including sample size calculation and definition of primary endpoint analyses procedures
- Coordinate and supervise service providers on statistical activities for a clinical study
- Ensure timelines and adequate quality of all statistical deliverables for the assigned trials and publications
- Develop and review statistical analysis plans (SAPs)
- Support in-house statistical programming of ADaMs, SDTMs, tables, listings and figures for clinical trials
- Validate meta datasets (define.xml) for electronic submissions
- Perform PK analyses for preclinical studies using SAS and WinNonLin
- Generate CTD-conform submission documents and process authorities' requests
- Provide adequate support to late-phase programs for all statistical tasks as required
- Provide innovative ideas for designing and analyzing clinical studies and support the set-up of statistically relevant processes and SOPs
Requirements:
- Diploma in statistics or mathematics or related field
- At least 5 years of experience as a biostatistician for clinical trials in the pharmaceutical industry
- Experiences in PK/PD studies, international Phase III and late phase studies
- Intermediate to expert experience of SAS programming (including SAS macro language) and experience in using NQuery Advisor for sample size calculations
- Ability to coordinate statistical activities for a clinical study
- Experience in CDISC standards
- Good understanding of global clinical trial practices, procedures and methodologies
- Good team player. Good business ethics
- Very good English (oral and written), German of advantage
Bitte melden Sie sich schnellstmöglich bei mir, falls Sie Interesse an dieser Position haben! Nähere Infos zur Stelle folgen telefonisch.
Vielen lieben Dank!
Herzliche Grüße aus München,
Carla Störzer