Excel-PPD招聘生物统计师，上海，1名

任职要求：制药企业或CRO相关职位1年以上工作经验，英语熟练。

Performs biostatistical activities for given clinical trials involving drugs, biologics and medical devices; provides statistical support to the project team.
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7 L) U, Q$ X- _4 x& A8 Z* gResponsibilities
        Participates in study design and develops statistical section in clinical trial protocols
9 }: _- [; y) k. ?7 \# u5 }6 s$ c        Develops and evaluates statistical methodology
6 P. [+ P' _4 i  f7 i        Performs sample size and statistical power calculations
        Generates randomization schedule
        Develops statistical analysis plans including table shells design for individual studies and integrated summaries of safety and efficacy (ISS/ISE)
  r0 c& m- y" q1 s" v2 I1 z5 |, }" E& H        Reviews protocols, statistical analysis plans or other study documents developed by other biostatistician(s) or consultant(s) and provides guidance
: E9 J- p/ k/ f5 x( P        Supports data safety monitoring board (DSMB) or data monitoring committee (DMC) and clinical endpoints committee (CEC) regarding to statistics analysis
        Supports for regulatory submission (e.g. NDA and PMA) including writing statistical part for eCTD
% q1 e, c2 G2 s! p, a        Represents biostatistician team at project team meetings and provides updates to project team on status of tasks
        Writes statistical report and participates in integrated clinical and statistical report writing
        Consults on other statistical tasks, such as support for CRF design, database development, data validation plan and blinded data review
$ \7 e0 O+ W) h3 X6 @        Performs SAS programming to generate tables, listings, figures, and statistical analyses
        Performs other duties assigned by supervisor

# ~) q) c) u" A8 {Qualifications
        An advanced degree (Ph.D. or M.S.) in biostatistics, statistics or related field
# ]3 E! t, \; i4 n6 ?        A minimum of 1 years experience of biostatistics and/or statistical programming applied to drug or medical device development; being familiar with CDISC data standards is desired
        Strong writing skills required to be able to write sections of protocols, statistical reports, clinical study reports, and randomization plans
        Experience of international drug development in a multicultural environment is a plus
  j* L8 @3 D1 L7 ?8 p' j        Ability to deal with sensitive inquiries or complaints from clients or potential clients and to protect confidentiality
  M  c" Q, n2 g  l( y        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
        Good communication and interpersonal skills, willingness and ability to encourage and support others to ensure the achievement of team goals.
) ~! ?- X( I0 o. ?2 N; }        Be able to make effective presentations in public settings
% J/ A/ P3 Z! C/ @        Proficient working in a PC/Windows environment
/ i" D: E% R" I: ?        A good command of English language if one’s native language is not English