Associated Director, Biostatisticis, Japan

Position Purpose:

The Statistical Scientist provides components of statistical contribution to a clinical development program. The Statistician implements statistical strategies for the clinical trials and regulatory submissions and is accountable for the statistical deliverables. The position will support the Japan clinical/PMS team with statistical expertise ad hoc analyses and interpretation of requests from PMDA. The Statistical Scientist will collaborate with the global CSL team on the design of global studies including Japan and on stand-alone studies conducted in Japan only. It is expected that the candidate will be experienced with PMDAs requirements regarding CDISC and to communicate these effectively to the global Biostatistics.

Reporting Relationships:

Report to Head Clinical Development R&D Japan

(This position also has a dotted-line reporting relationship to the Executive Director Transplant & Immunology Immunoglobulins & Processes Statistics Lead Global Biometrics in US/KOP)

Main Responsibilities and Accountabilities:

-Support Biostatistics to conduct study data collection data analysis reporting and submission preparation.

-Be accountable for timely completion and quality of the statistical analysis plan.

-Manage outsourcing operations for assigned projects.

-Ensure timeliness and quality of deliverables by CRO and conduct reviews of CRO deliverables to ensure quality.

-Support Biostatistics and data management related interactions with authorities (especially PMDA) including submissions to PMDA.

-Be responsible for compilation of the CDISC deliverables for the PMDA submissions and ensure its quality per the PMDA requirement.

-Be responsible for result accuracy in study report and regulatory submission documents.

-Manage preparation for the GCP inspections and lead the discussion at the on-site sponsor inspections related to data science areas (biostatistics data collection and data management)

-Conduct ad hoc statistical analyses.

-Support improvement initiatives and related standards for infrastructure / process / scientific consulting.

Position Qualifications and Experience Requirements:

Education

PhD or MS in Biostatistics Statistics or related fields.

Experience

-At least 5 years of experience in Clinical Development in a Pharmaceutical or Biotechnology setting

-Japan native preferred; Strong interpersonal and communication skills (verbal and written in English and Japanese)

-Ability to collaboratively work and provide leadership in a matrix environment

-Statistical support in facilitating and optimizing clinical development programs especially for global studies including Japan (sample size in rare diseases)

-Knowledge of CTD and CDISC submission requirements (SDTM and ADaM) for PMDA is highly preferred

-Experience managing CRO preferred

-Basic knowledge of clinical development and processes

-Experience with statistical programming using the SAS software

-Ability for overseas travel (mainly USA) once/twice a year

-Desired: Advanced knowledge and training in applications of statistical methodologies

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients needs by using the latest technologies we discover develop and deliver innovative therapies for people living with conditions in the immunology hematology cardiovascular and metabolic respiratory and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation recombinant protein technology and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

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