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本文来自:药物临床试验网论坛
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关键词:Biostatistician(生物统计师) Data manager(数据管理员) 百汇鹰阁Biostatistician(生物统计师) 5 l$ r& L1 P2 [0 ~9 H
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Responsibility:
9 k7 F9 }2 r _$ g' S5 B) `- Give statistical input to protocol with regards to design, sample size, choice of and analysis of endpoints ( h P; G5 ~# }6 e" {. {* k
- Review protocol, Case Report Form and Data Validation Plan
. J5 e# u( d# { ^- Prepare Statistical Analysis Plan (SAP) including table shells , `9 e# u" x) F" z# c) ~* `
- Prepare for and participate in database release meeting
8 ^4 [! l& q: d- t0 o6 _& {- Develop SAS programming, conduct statistical analyses and ensure preparation of output according to SAP * Z3 @2 x7 W1 S2 f1 ^3 a
- Validate statistical programs
! J! X' l! N0 {2 V J+ q9 N1 e+ t- Conduct additional analyses for publications of the trial
& A, p& [$ a9 g; [- Draft and review of Clinical Trial Report, presentation slides and scientific publications for statistical and scientific contents
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6 \$ e j O# @Qualifications:
0 Z K H1 F3 ?0 D- Minimum requirements: Bachelor degree in scientific or biomedical area, preferable major in statistics; ' T/ ]5 r3 t, [1 j
- Master degree is desirable,Or at least one year of biostatistician experience and working experience in public health and clinical trials is desirable;
8 K7 ?* x" B' P) a/ n- Considerable skill in SAS programming ; ?+ \' r: h, O/ B( g; V/ }
- Knowledge and experience in clinical trials
7 B6 [( }( g5 E# R/ W- Fluent in written and spoken English 3 j$ P2 c! s( S. g0 P7 Q
- Strong communication and coordinate skills, work as a team player
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6 @8 h& i7 [1 ZData manager(数据管理员)
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职责: , p6 n/ T9 H0 G% b! O- q& q3 V
- 与客户数据管理部门沟通协调 3 T) s( z9 P# V) N; Z C9 p. r
- CRF设计 - s- S' x2 F# }4 [7 S- q
- 数据库的创建、维护、备份与恢复 $ ]5 V2 r: ~8 P1 W' T
- 撰写数据管理计划
8 c; V- D7 m3 ]3 M- 撰写数据核查计划及编程
) f+ \0 {5 R! I- 注释CRF、原始数据库以及衍生SAS数据库说明,构建并验证数据库。
$ C/ t. x' K! T! G- 指导数据录入,保证数据质量
# P) G" m" h A, H2 N- 负责数据核查、修改、跟踪 8 t6 T' B7 z6 P2 Q q
- 数据质疑表管理 ! j* V+ p2 a0 ]8 |. C
- 负责数据库质量审查
) M6 K1 D# y& I- 负责数据医学编码 8 f- o% z& f5 E( h$ K; ^
- SAE一致性核查
* P1 O# v. A+ T3 z- 撰写数据管理报告
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: R8 H% Y5 a2 i; b0 y8 _Responsibility: - a1 m" ~% m5 |, m- \+ m$ t
- Communication with sponsor on Data management
: P7 i5 R5 t9 N0 A- w; \- CRF design : E4 }) k d& _1 D+ G* z
- Database creation, maintenance, backup and recovery ! Q5 \% }) l/ _6 C* N7 d1 C8 m
- Data management plan development
2 S; y) V6 Z6 P/ X- CRF annotation, database description and database construct/validation ) G& D) ]. ]/ s
- Data entry instruction and training, assurance in quality of data entry
! `& x, ~- V4 a& q- Data validation, update and audit trial
: P/ F$ K# H% k! s- Query management
3 v8 ~2 Q0 F, d6 }' H- Data quality control * `* h% U6 U5 ~3 }3 }; a- V" n
- Medical coding . X# R; R- y' n
- SAE reconciliation ~- r( E+ x0 _* J# i- W8 ~' T
- Data management report
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职位要求
( a! W# n4 |. T$ r- 流行病学、生物统计学、医学或相关专业本科或以上学历
2 a' w3 r+ G2 w- 2年以上数据管理工作经验,有临床试验工作经验者优先
, B1 n* Q+ ]8 r, R, l: Z+ ?- 了解ICH-GCP等临床试验指南
) V' r& A$ A# }5 _7 v, g! a- 熟悉SAS编程语言及SQL语言 . y% y- n6 B# b9 H1 r9 ]
- 良好数据库基础,熟悉ORACLE等数据库管理软件,有ClinTrial??檎哂畔 |
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