Location: New York,NY, USA
Anavex Life Sciences Corp. is seeking a talented and highly motivated statistician to join our team. This position will have full responsibility for the methodological and statistical considerations in the design, implementation and conduct of clinical studies as part of the development program team. He/She/They will provide technical expertise necessary for leadership and guidance on statistical matters interfacing with key internal and external stakeholders to support company initiatives that will improve the quality and content of all clinical programs to deliver our portfolio.
Key Responsibilities
* Support the clinical development program in designing clinical trials.
* Develop the statistical analysis plan (SAP), programing specifications, SAS programming for derived datasets, review and validate TFLs.
* Facilitate the implementation of statistical analyses, provide statistical input to the clinical study report and scientific presentations/manuscripts.
* Perform statistical functions for submission related activities and serve as an internal statistical expert for the program.
* Interface with therapeutic area members including Clinical Development, Data Management, Clinical Operations, Translational Science, Regulatory Affairs and Publication Teams.
* Participate in managing vendors to ensure quality of all deliverables and adherence to requirements/timeline.
* Participate in process improvement, training, SOP development, enhancing statistical technical expertise and mentoring junior statisticians as a senior member of biostatistics department.
Position will be filled at level commensurate with experience.
Requirements
* Ph.D in statistics or biostatistics with at least 5 (Associate Director), 8-10 (Director), or 13 (Senior Director) years of experience in the biotechnology/pharmaceutical industry. Exceptional MS/MA candidates will also be considered.
* Deep understanding of statistical designs and methods for early and late development programs.
* Solid understanding of regulatory guidelines on drug development, regulatory submissions, and statistical practice.
* Experience in applying quantitative decision-making methods to support internal Go/No-Go decisions.
* Significant prior experience interaction with health authority agencies such as FDA and EMA.
* Demonstrated track record of successful project management (6+ years) and evidence of leading role as biostatistician in progressing assets from early development to marketing applications.
* Outstanding ability and skills to effectively represent Biometrics and Data Management in interaction with senior management or cross-functional teams.
* Proficient in SAS, S-Plus/R, sample size calculation software and statistical programming (SDTM/AdaM).
Remote position; intermittently required to work on-site in New York City; occasional travel.