The Role
The AD, Biostatistics will be supporting clinical development with a focus on phase I-III trials, the position will work with the clinical and regulatory team in designing clinical trials, developing the statistical analysis plan, overseeing statistical deliverables and interpretating analysis results.
Responsibilities:
- Participate in process improvement, training, SOP development, enhancing statistical technical expertise and promoting sound practice that brings statistical rigor to our clinical trials.
- Interface with clinical therapeutic area members, SAS programming, clinical data management, clinical operation, clinical pharmacology, medical writing and other functions.
- Participate in managing vendors to ensure quality of all deliverables' and adherence to requirements/timeline.
- Supporting clinical development with a focus on phase 1-3 trials, the position will work with the cross-functional team to provide the statistical support to the clinical study team which includes protocol development, CRF review, vendor selection and specification review (e.g. IRT, imaging and iDMC), SAP development, dry run review, interim and final analysis planning and CSR review.
- Facilitate the implementation of statistical analyses, provide statistical input to the CSR and scientific presentations/manuscripts, perform statistical functions for submission related activities and serve as internal statistical expert at the study or project level
- Provide statistical guidance to clinical and programming team in generating TFL outputs for conference and journal publication.
Qualifications: About you
- A minimum of a master's degree with 6+ years of experience or a PhD in Statistics or related field with 4+ years of experience in clinical drug development is required.
- Knowledge of SAS and/or R is strongly desirable.
- Familiarity with CDISC requirements for SDTM and ADaM
- Experiences with clinical trials and knowledge of regulatory guidance are required.
- Oncology experience is required