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Pfizer 、Novartis 招聘生物统计师Statistician ' \) u# }/ A$ o/ b$ _( V9 G8 [
工作地点:上海、北京皆可
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Position: Clinical Statistician' w2 f2 s/ O! H' ~* N+ U
Zone / Line: Medicine Development Group, Primary Care Business Unit% m0 q% u" v$ a" g; e& P% U! W
Department: Statistics, Pfizer China Research & Development Center (CRDC)6 X8 \$ }1 X' G0 i3 h8 x
Career Ladder: D2/D39 u: I9 r- u' P& ]) j; c
Location: Zhangjiang, Shanghai
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Position Purpose:
0 y5 T7 D, t5 [• Design, Analyze, and Interpret Clinical Trials+ p# d, |- ~1 I5 H
• Provide statistical expertise and contributions for projects and protocols in support of Clinical development.) ?7 {9 H( v" U2 g/ Z; d8 J2 k
• Provide statistical expertise on regulatory submissions and ensure quality and appropriateness of submission deliverables. 5 |( o' l. ~/ `1 ~% v& a
• Provide statistical expertise to maximizing the value of aggregate clinical data in support of scientific and drug development strategies.( w* s% I4 Q6 u& p9 [
• Provide study level statistical leadership and communicate resource needs to management and other line functions for the execution of statistical tasks.
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/ i. `9 Z/ I8 d5 j1 m: [" @3 bOrganizational Relationships:
0 Y! J7 c& b9 C( t6 D1 Z• Reports to the local Site Head, Statistics
. X( {1 t+ ^' m# i+ o# a$ a. n• Matrixed relationship with other members of study team: Clinicians, Clinical Pharmacology, Clinical Programming & Writing (CPW), Study Manager, Protocol leads, and Project Leads in Regulatory.
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& n* j7 q; ?, p2 G* r7 o" T! NQualifications and Responsibilities:3 B# F- H4 B9 i- k
8 m1 ?9 r+ w+ t0 u( V; WQualifications: c, i& r, L" I( w1 T4 U# B
• Advanced degree in statistics, biostatistics, or related field. Experience in clinical trials is desired but not necessary.
: ^) v) B5 t( y7 v* y) L2 E) @9 `• Capability to provide statistical leadership to cross -functional teams at the protocol level.1 P- Q* m% Z" E$ U/ q2 O
• Strong statistical skills with application to clinical trials.
6 B- B F! H/ o \! A6 c- S• Effective verbal and written English communication skills in relating to colleagues and associates both inside and outside the organization.
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0 e s" v2 i, E; O6 |* C5 ?4 T# S+ }Responsibilities:8 M; f4 m) Q& R5 {& t! E) |& F
• Through effective partnership with lead project statistician, provide statistical input to study design, statistical analysis plans, interpretation of statistical results, project development plans, regulatory issues and scientific and commercialization projects
9 s- S% U7 p# W! i0 m• Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results, exploratory and meta-analysis results, support for publication activities, scientific presentations, and support to product defense.
' i6 O5 r8 [( T( R2 p• Accountable for study level and submission level statistical deliverables on assigned projects.
9 C1 y% ~$ {) o* r9 U• Develop effective collaborations with others within Clinical R&D (clinicians and pharmacokineticists), and external regulatory, industry, professional and academic organizations.
/ o( b, ~2 `6 H# t+ U$ S• Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.
4 D+ @3 R# |: G. E• Provide statistical input and leadership to cross-functional activities – collaborate with other statisticians, study managers, CPW colleagues – for assigned studies and regulatory submissions / u& D; D% ?1 u) G; v: P5 R2 t9 `
• Provide input to management plans to support assigned studies and submissions.
- `; n5 v. |0 _1 g• Ensure timeliness and quality of statistical deliverables according to project plans for assigned studies and projects.
, E! q" E! r: m2 I• Comply with all statistics and quality processes and standards that are applicable to statistical outputs, and support processes that require statistical input. t8 n1 P% L+ E( ~# @7 \' Z
• Communicate and collaborate with other project statisticians within the therapeutic area to ensure consistency of statistical approaches 7 P# n% m4 e' L2 D5 h1 p
• Provide a strong statistical presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice.
$ { n* I1 i/ P8 u* J% M2 _* @• Participate in research on statistical methodology and its applications pertinent to business needs.
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) v* q4 h* S0 u5 s: sPrior Experience Preferred
5 i* ^1 Q' `/ [" S' d- ]. d7 E- \3 _2 G• Relevant clinical trial and business experience providing an understanding of the processes associated with clinical, regulatory and marketing operations.; b, S% G8 u. g4 y' k G& P8 f
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Competency:
0 ]# f9 H8 F7 |# _4 X9 p• All vary with Career Ladder level with increasing competence expected at more senior grades and with greater emphasis on assessment of potential at more junior grades
+ B: ^" D1 O+ m' J• Able to provide timely and quality statistical contributions and scientific reporting of clinical trials for regulatory submissions
l7 B# o$ f; U5 g# J) w0 W R• Strong analytic skills, well-organised, clearly documents what has been done, is aware of and adheres to relevant SOPs
4 W3 `2 z6 W; ^& ` \2 z• Able to manage complex projects and cross-functional processes' _8 P* K5 }# w, T3 d G4 t
• Familiar with and comfortable using deployed technologies and tools; identifies new opportunities and emergent needs and acts on them3 |' N! J& ]3 i* Q3 T, L
• Strong presentation and communication skills working with colleagues at Dev sites; able to effectively communicate technical material to non-technical audience; proactively proposes new ideas and able to refine ideas of others
" h& z q. n& l+ s+ d• Excellent written English and communication; X* x: ?1 m% Q$ B
• Strongly focused on identifying and understanding the needs of key customers and ensuring productive working relationships
" D0 v* a3 i9 S1 E7 d& ~• Able to work effectively in a multi-cultural and diverse business environment spanning international borders and time zones
5 ^) l' m! Y [• Utilizes, encourages and shares innovative approaches to build and maintain a competitive advantage
; l% H a) L Q+ e. o• Able to work effectively within a complex organization to influence key stakeholders/ e) I" k' y7 d6 @5 P8 A' z* ^
• Looks for opportunities for collaboration and acts upon them
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统计学相关专业,博士优先,有海外学习或者项目经验者更佳,薪资待遇优厚" I4 h9 a i, d- D6 }
联系方式:TEL:13917297754
. _7 A1 C0 N( j Mail:lietoubeyond@网易126邮箱 ) @+ G9 }! @# x8 Q
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