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Pfizer 、Novartis 招聘生物统计师Statistician
# k! W1 Q3 o: z+ u3 l' Y! f工作地点:上海、北京皆可! C W* O- S- G( Q9 A
9 Z1 _* ?6 ?- X, W4 S" M" j6 [Position: Clinical Statistician
$ L" v- i) T2 n/ A) q1 X# n3 k; AZone / Line: Medicine Development Group, Primary Care Business Unit2 m% K9 C3 i6 o% h1 d- y: l
Department: Statistics, Pfizer China Research & Development Center (CRDC)4 ?5 y9 w6 V2 c
Career Ladder: D2/D3
9 u+ r/ z# X# R. A6 FLocation: Zhangjiang, Shanghai
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' X- G" i' X; B; ^" t7 u) C- M2 a. oPosition Purpose:/ P$ L+ p# i3 }9 I2 B& X! ]% F' D
• Design, Analyze, and Interpret Clinical Trials3 O0 Y8 {0 W |7 d9 f' {
• Provide statistical expertise and contributions for projects and protocols in support of Clinical development.9 `( Y! p. n5 Y; C+ c; ^
• Provide statistical expertise on regulatory submissions and ensure quality and appropriateness of submission deliverables.
; u% E- g1 o+ N• Provide statistical expertise to maximizing the value of aggregate clinical data in support of scientific and drug development strategies., S0 D& O! L: Y; e* R
• Provide study level statistical leadership and communicate resource needs to management and other line functions for the execution of statistical tasks.. V) x; v1 v6 r1 N% {/ [
, \) r5 w" l9 W$ kOrganizational Relationships:6 r4 y! w4 K% K' b$ b
• Reports to the local Site Head, Statistics
; k% a. Q6 F& v: F9 Q2 Z d6 M• 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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Qualifications and Responsibilities:7 v" w7 m& q3 p6 h( ]
9 ~4 ^( W4 ]/ O3 K9 d8 oQualifications:( h" I, U( n3 R; ]+ A2 D+ ^; d
• Advanced degree in statistics, biostatistics, or related field. Experience in clinical trials is desired but not necessary.4 U# F) b3 |- h
• Capability to provide statistical leadership to cross -functional teams at the protocol level.
' u$ q1 K U$ q( c. L7 e1 u• Strong statistical skills with application to clinical trials. }2 V* o3 F! X' j4 V7 v
• Effective verbal and written English communication skills in relating to colleagues and associates both inside and outside the organization.$ g0 x% w2 l5 x
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Responsibilities:' n" P" }+ B) J5 v
• 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 projects0 [( @# ]0 ~1 m6 N% @& U3 }( ]
• 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.( z1 @- B6 X3 e' |% S! d
• Accountable for study level and submission level statistical deliverables on assigned projects.
" Q% G( k U: e% ?2 d0 w+ l" p• Develop effective collaborations with others within Clinical R&D (clinicians and pharmacokineticists), and external regulatory, industry, professional and academic organizations.
$ F# q( b; c$ Y- [. j- [& n9 |" y• Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.
& @0 L8 W* z+ K7 I p• Provide statistical input and leadership to cross-functional activities – collaborate with other statisticians, study managers, CPW colleagues – for assigned studies and regulatory submissions
9 f7 F- s7 Y) [+ g5 a3 S• Provide input to management plans to support assigned studies and submissions.
, m* g K! D! f( n. Z• Ensure timeliness and quality of statistical deliverables according to project plans for assigned studies and projects. J- ?, r% x0 V
• Comply with all statistics and quality processes and standards that are applicable to statistical outputs, and support processes that require statistical input.
" K0 _+ z' M: T) i. y9 x& z• Communicate and collaborate with other project statisticians within the therapeutic area to ensure consistency of statistical approaches 7 W: K# B% A$ {
• Provide a strong statistical presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice.. Y8 s3 z) h* U$ Q
• Participate in research on statistical methodology and its applications pertinent to business needs.& h- N% Z4 S3 s) Q; A
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Prior Experience Preferred
2 c9 L7 \: l$ g9 }9 ]; _1 u- O• Relevant clinical trial and business experience providing an understanding of the processes associated with clinical, regulatory and marketing operations.
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0 l. x* \$ Q; pCompetency: 5 \/ |5 `5 S& m7 q3 u& q
• 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
/ }; L7 b+ K: T6 I• Able to provide timely and quality statistical contributions and scientific reporting of clinical trials for regulatory submissions5 z' p3 A3 o5 D5 K
• Strong analytic skills, well-organised, clearly documents what has been done, is aware of and adheres to relevant SOPs4 r' n- ?" N- R. L! Y! o4 v
• Able to manage complex projects and cross-functional processes$ m6 t3 J$ ~# C* z' r
• Familiar with and comfortable using deployed technologies and tools; identifies new opportunities and emergent needs and acts on them& y# a, O3 Y3 P+ D* ~) _! o
• 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
# p2 o% t. k2 m& ~! ~& q9 |/ F! L• Excellent written English and communication
6 B3 x/ c6 W2 A, s! K. t• Strongly focused on identifying and understanding the needs of key customers and ensuring productive working relationships
9 ]6 L! a1 ^4 t6 @# N% U6 J5 F5 h* z• Able to work effectively in a multi-cultural and diverse business environment spanning international borders and time zones
1 B$ S) u5 W" ^6 }' x' k7 _• Utilizes, encourages and shares innovative approaches to build and maintain a competitive advantage$ n# ?6 V3 d @$ |1 |- ?: |- y: t- G) M
• Able to work effectively within a complex organization to influence key stakeholders% f" D, c0 m1 r) U# {
• Looks for opportunities for collaboration and acts upon them4 ^5 }+ D% `, }% O
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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
5 C9 h1 y/ ^# x7 I' \& Y! M6 n: t联系方式:TEL:13917297754% W5 |1 W. ]6 P- x% l
Mail:lietoubeyond@网易126邮箱
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