发帖
雷达卡
Responsibilities
1）Participates in clinical development plan, study design and develops statistical section in
clinical trial protocols
2）Develops and evaluates statistical methodology
3）Performs sample size and statistical power calculations
4）Generates randomization schedule
5）Develops statistical analysis plans including table shells design for individual studies and
integrated summaries of safety and efficacy
6）Reviews protocols, statistical analysis plans or other study documents developed by other
biostatistician(s) or consultant(s) and provides guidance
7）Supports data safety monitoring board (DSMB) or data monitoring committee (DMC)
and clinical endpoints committee (CEC) regarding to statistics analysis
8）Supports for regulatory submission (e.g. NDA and PMA) including writing statistical part
for eCTD
9）Represents biostatistician team at project team meetings and provides s to project
team on status of tasks
10）Writes statistical report and participates in integrated clinical and statistical report writing
11）Consults on other statistical tasks, such as support for CRF design, database development,
data validation plan and blinded data review
12）Consults on analysis strategies for interim analysis and integrated summaries of safety
and efficacy (ISE/ISS)
13）Performs SAS programming to generate tables, listings, figures, and statistical analyses
14）Mentors and trains low level biostatisticians and new colleagues
15）Provides technical support to the biostatistics team
16）Performs other duties assigned by supervisor
Qualifications
1）An advanced degree (Ph.D. or M.S.) in biostatistics, statistics or related field
2）A minimum of 4 years (for M.S.) or 2 years (for Ph.D.) experience of biostatistics and/or
statistical programming applied to drug or medical device development； being familiar
with CDISC data standards is desired
3）Strong writing skills required to be able to write sections of protocols, statistical reports,
clinical study reports, and randomization plans
4）Significant statistics experience in CRO or pharmaceutical R&D including all phases and
large studies
5）Experience of international drug development in a multicultural environment is a plus
6）Ability to deal with sensitive inquiries or complaints clients or potential clients and
to protect confidentiality
7）Be knowledgeable in all aspects of the drug agencies (e.g. FDA) regulations and
requirements governing the conduct of drug and medical device studies including, but not
limited to, GCP and ICH requirements
8）Excellent communication and interpersonal skills, willingness and ability to encourage
and support others to ensure the achievement of team goals.
9）Be able to make effective presentations in public settings
10）Proficient working in a PC/Windows environment
11）A good command of English language if one’s native language is not English
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