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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)
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8 N0 D8 @' W0 Q# |# b- X2 YResponsibility:
- l" b3 \. f! d6 u2 d) l- Give statistical input to protocol with regards to design, sample size, choice of and analysis of endpoints ( H/ o, K, U3 k, f
- Review protocol, Case Report Form and Data Validation Plan ( @% u; j& \ |* M7 h+ z, T
- Prepare Statistical Analysis Plan (SAP) including table shells
* s$ D4 g C- E+ ~& N6 M' ~- Prepare for and participate in database release meeting
9 Z. L: {& _/ ~! R7 E! z- Develop SAS programming, conduct statistical analyses and ensure preparation of output according to SAP
9 v1 ^0 [8 {" t! m; Z- Validate statistical programs 0 O$ T* @/ V0 J/ G0 X5 q
- Conduct additional analyses for publications of the trial 4 V2 T; f. F9 s4 V$ n2 R& P
- Draft and review of Clinical Trial Report, presentation slides and scientific publications for statistical and scientific contents . }% D: d. ^( R( b% X" m9 r
( P9 o* ~; } f7 Z, LQualifications:
& A+ {) t% i: X* q- Minimum requirements: Bachelor degree in scientific or biomedical area, preferable major in statistics;
, {- ]8 M5 V* d3 N6 C7 o" ]: h, h- Master degree is desirable,Or at least one year of biostatistician experience and working experience in public health and clinical trials is desirable; / @& q& A* Y: [( j4 ^5 Q
- Considerable skill in SAS programming $ Q7 e/ U& u) v2 a4 ]/ g' @9 f
- Knowledge and experience in clinical trials
& ]' a% C/ h& c' T6 Z" U- Fluent in written and spoken English # Z6 I+ e7 n+ ] J$ D# Q1 p/ J6 }
- Strong communication and coordinate skills, work as a team player # V- J: e5 a* m4 t) _) y
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% Y* `: U& B* |2 f+ _/ Z/ B+ w3 P+ @Data manager(数据管理员) ( V- h: Q7 O* E( O
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职责: D9 G, [: A; |8 z
- 与客户数据管理部门沟通协调 - g& n" e5 h8 _' }& d
- CRF设计 : R, r: Z+ E7 d) s
- 数据库的创建、维护、备份与恢复
) e E. W# ]& g3 M4 q% g A- 撰写数据管理计划 / S# s; _4 Q3 b7 L
- 撰写数据核查计划及编程
- C$ F+ S( n5 P# ]! F, f6 Q/ v# Q- 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。 1 @& a1 X% z% s
- 指导数据录入,保证数据质量
/ |: d* H2 k" h6 ~ K) t* j$ I& [- 负责数据核查、修改、跟踪 - g& T0 P l1 N0 i
- 数据质疑表管理 + G* r" K3 r8 A* H- w
- 负责数据库质量审查 4 U) l. s# Z# x' {; s! Y+ g6 A% Y
- 负责数据医学编码 " I0 Q# V/ @# i: n. u" r; h3 e# ?
- SAE一致性核查
7 B1 C$ P8 Q; {: V- j: Y0 Z- 撰写数据管理报告
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Responsibility: 5 m* y: L& H* ^1 {9 \/ X
- Communication with sponsor on Data management
& L& h5 k* m& l" S- CRF design # c* l& G0 O; `9 [
- Database creation, maintenance, backup and recovery
/ u4 i; D. `& t& b$ N, \6 {# X- Data management plan development
3 p T# y$ f$ \/ J! O- CRF annotation, database description and database construct/validation k6 Y$ V2 Z( M# u( y7 q8 |
- Data entry instruction and training, assurance in quality of data entry
, }0 a5 v/ I6 ~- Data validation, update and audit trial
- p u. B( V8 P% I2 h- Query management ( d$ x; e/ n6 Y' {# s7 ]
- Data quality control
, }# s: h ~; E9 I- Medical coding ( g# v$ v; @$ k" L% V. H" r
- SAE reconciliation
5 @3 {6 C( N- h2 f0 p" x: S9 z- Data management report + f d. @8 P2 X7 I+ C
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- {+ w: J/ T6 C7 w0 o& d职位要求 9 r! @% _7 I9 s) N6 @4 Q% p( h E
- 流行病学、生物统计学、医学或相关专业本科或以上学历 4 H, |- ^' ? d+ h+ v
- 2年以上数据管理工作经验,有临床试验工作经验者优先
7 l" V. z- @" F. t4 j7 l& d" m* r- 了解ICH-GCP等临床试验指南 % ?/ ]1 `3 K+ k
- 熟悉SAS编程语言及SQL语言 2 V- s! E6 r7 r
- 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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