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Pfizer 、Novartis 招聘生物统计师Statistician
- |, [8 X1 Q7 S. z+ F工作地点:上海、北京皆可
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0 ?2 d i W" l; uPosition: Clinical Statistician
1 T+ o' y, ~, Z" GZone / Line: Medicine Development Group, Primary Care Business Unit1 ~' B1 R, v! K4 L' t+ a
Department: Statistics, Pfizer China Research & Development Center (CRDC)
$ A( ]7 M8 x* z E4 hCareer Ladder: D2/D3
5 C5 R% ]/ n8 W9 BLocation: Zhangjiang, Shanghai4 l3 }: N. e, }" w
* \( u- k" M$ Y+ b3 UPosition Purpose:
9 M' p1 B5 d- S• Design, Analyze, and Interpret Clinical Trials
f1 o9 }$ r4 W• Provide statistical expertise and contributions for projects and protocols in support of Clinical development.
1 Q# I$ P! o! T, R: y" o- U* h• Provide statistical expertise on regulatory submissions and ensure quality and appropriateness of submission deliverables. 0 D' ?& K" g% Y1 {6 _( m, Q- |
• Provide statistical expertise to maximizing the value of aggregate clinical data in support of scientific and drug development strategies., R, X2 b1 J! g* G8 |
• 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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1 h7 j0 x: {3 e3 s! dOrganizational Relationships:
" N3 n8 a! t+ m5 }# \9 O' X• Reports to the local Site Head, Statistics g8 f4 L/ V; E, X b0 b T0 C
• Matrixed relationship with other members of study team: Clinicians, Clinical Pharmacology, Clinical Programming & Writing (CPW), Study Manager, Protocol leads, and Project Leads in Regulatory.# G- J" e5 L" l! n: u6 O& o0 w
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Qualifications and Responsibilities:- b8 W1 X, x% ]$ Y7 I1 Z; x& F
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Qualifications:* n; W, @8 T9 f+ j: `8 Z7 Q
• Advanced degree in statistics, biostatistics, or related field. Experience in clinical trials is desired but not necessary.
% C. ~! y. t" \# S9 j, s8 X, k• Capability to provide statistical leadership to cross -functional teams at the protocol level.
& I- X1 l$ K' o( P1 l7 j6 `• Strong statistical skills with application to clinical trials.6 j) @4 y% |3 s7 j
• Effective verbal and written English communication skills in relating to colleagues and associates both inside and outside the organization.. U7 Y1 q& z$ t
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Responsibilities:
6 E9 ]3 m1 E$ C: m$ T• 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$ V( P' L3 V4 B3 I
• 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.
$ D+ x- r$ ?+ \" m" }• Accountable for study level and submission level statistical deliverables on assigned projects.$ ^4 k. c) r6 U% n9 K
• Develop effective collaborations with others within Clinical R&D (clinicians and pharmacokineticists), and external regulatory, industry, professional and academic organizations.5 \" V4 f9 ` h3 V7 ^2 o" I
• Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.* ^; w) |/ i( d& }# p
• Provide statistical input and leadership to cross-functional activities – collaborate with other statisticians, study managers, CPW colleagues – for assigned studies and regulatory submissions . `2 t: I4 G* a+ p1 h8 e% `& Q
• Provide input to management plans to support assigned studies and submissions. . f7 G/ c8 T7 V- p( U8 b5 d
• Ensure timeliness and quality of statistical deliverables according to project plans for assigned studies and projects.
I- Y- p1 c! j5 L$ r8 z• Comply with all statistics and quality processes and standards that are applicable to statistical outputs, and support processes that require statistical input.1 p& p" e* ?5 G% q8 k7 c1 \
• Communicate and collaborate with other project statisticians within the therapeutic area to ensure consistency of statistical approaches " v, ~# o6 B( t- t
• Provide a strong statistical presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice.
p' y1 {+ `/ T6 P+ H0 r• Participate in research on statistical methodology and its applications pertinent to business needs.5 y5 t/ I9 { I4 \) |
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Prior Experience Preferred
* H( b# X' h- E! s8 r• Relevant clinical trial and business experience providing an understanding of the processes associated with clinical, regulatory and marketing operations.
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' D( k* Z" ?$ VCompetency: 5 n4 n; `1 Q% G. H" O* h# @
• 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
! k I, p8 j+ l1 I4 O c• Able to provide timely and quality statistical contributions and scientific reporting of clinical trials for regulatory submissions0 D9 Q4 b2 L+ D; M) m0 C4 D
• Strong analytic skills, well-organised, clearly documents what has been done, is aware of and adheres to relevant SOPs+ s; E0 W9 X$ ], y& }' U( m
• Able to manage complex projects and cross-functional processes
- o5 s* G) Q5 R% ]' f4 L• Familiar with and comfortable using deployed technologies and tools; identifies new opportunities and emergent needs and acts on them
3 I V F8 o7 W$ I, y7 H• 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& |5 g2 S# ?8 _, T
• Excellent written English and communication
' @0 ?. R9 O8 S0 G# Z. \- T• Strongly focused on identifying and understanding the needs of key customers and ensuring productive working relationships$ K$ b2 i" A& B9 H2 @8 r; t/ T
• Able to work effectively in a multi-cultural and diverse business environment spanning international borders and time zones8 y* J( `0 b, e9 k
• Utilizes, encourages and shares innovative approaches to build and maintain a competitive advantage
5 Q* E) o$ U$ m! \$ a7 B7 f" S) l• Able to work effectively within a complex organization to influence key stakeholders
* A' _! p) z$ s c• Looks for opportunities for collaboration and acts upon them J4 r. }. N1 B h7 t
3 g* v% T( _( Y: J; U0 G$ `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 Q! l2 `- Z. p$ Z* w3 E联系方式:TEL:139172977547 M5 t0 q& C0 u8 z
Mail:lietoubeyond@网易126邮箱
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