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公司名称:北京百汇鹰阁医药技术咨询有限公司(Gleneagles CRC pte Ltd.)
7 s- f W4 [" \: A+ C/ h) S公司网址:http://www.gleneaglescrc.com
9 ^; |' j" h, ?7 R: {, t; V公司性质:新加坡独资
& p% p. x# N$ k4 \" P$ L联系人:廖先生
K7 i( I- r( S0 `; L# [" A电子邮箱:ericliao@gleneaglescrc.com
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招聘职位:
9 @% T# Y/ T$ {+ `1.Biostatistician(生物统计师) 8 j6 T8 G' F k; N0 G) Q! e, o
Responsibility: ! x/ ^+ T" ~% p: ^4 I9 y) N' R
 Give statistical input to protocol with regards to design, sample size, choice of and analysis of endpoints 8 o/ r, H7 Y$ y3 @2 c, _
 Review protocol, Case Report Form and Data Validation Plan
; r" u# ]3 [) g P' r" X, p Prepare Statistical Analysis Plan (SAP) including table shells 5 i0 h1 x% q; E S4 [8 i& L
 Prepare for and participate in database release meeting
- ^1 C, u8 \4 f& o# ^ Develop SAS programming, conduct statistical analyses and ensure preparation of output according to SAP $ o: k8 @/ t$ g0 H3 l8 d
 Validate statistical programs
$ O, \% G$ R& K6 G5 Z: P7 s* h$ \ Conduct additional analyses for publications of the trial
9 D( N7 X, N% D4 O# b7 Y L. N Draft and review of Clinical Trial Report, presentation slides and scientific publications for statistical and scientific contents
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2 e' G2 z/ Z* T7 uQualifications:
& w4 }0 \4 V; F( y8 ^% | Minimum requirements: Bachelor degree in scientific or biomedical area, preferable major in statistics;
% _/ Z, @; w. P Master degree is desirable, and we’ll resolve Beijing Hu-kou for excellent graduating students. ' V5 r/ X S8 I! |+ p; Y, n/ F
 Or at least one year of biostatistician experience and working experience in public health and clinical trials is desirable; $ ~! f& ?6 K0 q6 ]5 A) t6 I' m: v
 Considerable skill in SAS programming
$ V1 T, L% Y9 k$ D0 h/ v Knowledge and experience in clinical trials c0 i8 O5 }- W2 r: O- |
 Fluent in written and spoken English 2 ]8 D+ t( ?6 e( M! |
 Strong communication and coordinate skills, work as a team player - e) [$ H$ \$ t- `- y+ Y* J
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备注: 非北京生源应届硕士生优先,可解决户口。
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2.Data manager(数据管理员)
7 N" k+ c4 x. X7 K2 i职责:
2 B3 G$ u0 ~3 k; _2 M5 X; ]- i 与客户数据管理部门沟通协调 H- _' l6 C- _* b& E6 c, q
 CRF设计
1 m4 S- Q5 X u. a3 k 数据库的创建、维护、备份与恢复 - q8 R2 s4 P5 L
 撰写数据管理计划
; r7 F- k6 F2 U$ o7 J# e% \ 撰写数据核查计划及编程 ( ~# Y! o4 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。
+ f9 x- Z. W/ f9 O! i4 Z9 z3 { k 指导数据录入,保证数据质量
! p3 J s, J; I" |- r, `/ h 负责数据核查、修改、跟踪 , R S# W) E6 l$ G
 数据质疑表管理 ! Y8 P' p0 K9 N6 p3 J; A ]
 负责数据库质量审查
& J3 m0 k, M3 Z/ ?/ u. K 负责数据医学编码
; i( I( ~- q6 h6 j SAE一致性核查
/ i: z; ^9 `% ?* X4 U 撰写数据管理报告 2 _& X! g6 q, {+ @' a
' n5 }8 ?. Z: Z9 E9 HResponsibility:
" { C3 }- Q. s2 |& R5 l9 ~# Q9 C [ Communication with sponsor on Data management
2 b# D4 T W2 V& w$ S. J5 V. { CRF design ( w( |2 ^/ |0 t3 \1 e8 k; w
 Database creation, maintenance, backup and recovery " w1 V! |# o8 h2 C
 Data management plan development
9 Q8 s8 K# @+ \1 x" c CRF annotation, database description and database construct/validation $ }: Z V: a7 _7 |
 Data entry instruction and training, assurance in quality of data entry
! Y: o! Q/ K; \5 G* }* S Data validation, update and audit trial
$ n9 m' \6 j4 n) Q5 \+ e* e6 C Query management
( ~2 O8 {6 t2 X5 K p% { Data quality control 4 u9 t& k- x$ j. ?- Q
 Medical coding ( u4 v" A0 ]6 g3 r. b
 SAE reconciliation 6 W+ K' W; [7 i& l+ T( b. t- Y
 Data management report
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职位要求 * K W/ h2 b5 E' V. Q0 H, s
 流行病学、生物统计学、医学或相关专业本科或以上学历
* i7 O5 b& [" _8 N2 O 2年以上数据管理工作经验,有临床试验工作经验者优先 # b- X% T' z$ _. j) ~% R1 d
 了解ICH-GCP等临床试验指南 9 |' k& C: B/ f. P' _7 x; t
 熟悉SAS编程语言及SQL语言 4 W; U% a% E' y
 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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