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PPD is a leading global contract research organization (CRO) with more than 12,000 professionals and offices in 46 countries worldwide. PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. L: T, G( V2 S4 Q
: Q' g0 d0 ~; x# L' ZAs part of our ongoing growth we are currently looking to hire Programmers Analysts and Sr. Programmers Analysts to join our rapidly expanding team. A junior level but having high potential may also be considered.8 N5 U. w1 V0 w1 l) B0 W
" {# |4 u& \0 s* D& H8 G4 G g4 A1. Programmers Analyst
( O6 q) t. f# J; d: uEssential Responsibilities L _. N, \) B& t3 s
% U# g4 G3 F( U: F- F6 I7 g% v) x- Be familiar with and follow the departmental and company standard operating procedures (SOPs) and working practices (WPs).
- Serve as a lead statistician on selected single projects.
- Ensure projects are well documented consistent with company SOPs and working practices.
- Time management of own and team's time spent on projects.
- Interact with the sponsor on statistical aspects of the project.
- Produce sample size calculations. Provide input into study design and statistical considerations, during protocol development. Review protocols for completeness, appropriateness of clinical design and sound statistical analysis. Contribute to writing appropriate protocol sections.
- Provide randomization schemes and appropriate documentation, on selected projects.
- Develop statistical analysis plans, including table, listing and graph specifications.
- Specify the general structure of the analysis database, provide programming support for its development and validation.
- Produce statistical analyses and statistical appendices, with appropriate documentation.
- Validate statistical analyses and statistical appendices, with appropriate documentation.
- Prepare Statistical Reports, Integrated Summaries of Safety, Integrated Summaries of Efficacy and other documents, as required. Contribute statistical methods section for Integrated Clinical Statistical Reports. Review Integrated Clinical Statistical Reports.; y/ I/ u/ _$ b; |
& _- k( p8 a# ^/ F0 P% Z9 IQualification
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1. A Master or Bachelor degree in biostatistics, statistics or related field.
+ n/ J' R# O1 T* G P4 k, `3 x2. A minimum of 1 years (for M.S.) or 2 years (for Bachelor) experience of statistical and/or statistical programming in CRO or pharmaceutical R&D including all phases and large studies applied to drug or medical device development.
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Skills& O0 R1 M6 c6 C0 l5 k+ C
+ P$ w+ j( ]& u: M9 W \1. Strong writing skills required to be able to write sections of protocols, statistical reports, clinical study reports, and randomization plans
# e* J- @( n; S$ M2. SAS® programming skills and familiarity of other statistical packages (e.g. StatXact, nQuery) and understanding of database structures
7 J% u* {. a! I) t4 C& ]2 _" d3. Experience of international drug development in a multicultural environment is a plus0 ?# q% J) y3 j6 W
4. Being familiar with CDISC data standards is a plus8 w8 T) e# {2 Z5 A. _
5. Excellence in planning, managing and coordinating statistical and statistical programming activities in clinical trials; previous management experience of statisticians is preferred: P7 y) Q) d D* }* W
6. Ability to deal with sensitive inquiries or complaints from clients or potential clients and to protect confidentiality
' Q3 M& u! [2 J) f9 l% |) `% Y: q7 y7. Excellent communication and interpersonal skills
" v( l x L9 `5 N3 k: {8. Sufficient active written and oral English communication skills6 [9 l: @6 H" K+ U+ t
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2. Sr. Programmers Analyst @% j5 |" |5 _7 B' j& W
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Key words
4 }* K. q$ `( t4 L3 t$ ~SAS, C++, JAVA, PROGRAMMING, STATISTICS, MATHEMATICS: i" z" @+ A& Z; k
v& K: O' Z" ]& i. D5 l6 {Major Required:: }- w8 t4 y# Q, |+ U+ q+ `- E
Master or Bachelor degree in biostatistics, statistics or related field. Other majors like Mathematics, Engineering, Physics are acceptable if have strong IT (ORACLE, JAVA, C++) and English background. % C A/ R) b6 `( O" H- x9 m
: I- t! R- ^3 Z% c' n7 |Essential Responsibilities
! {4 U9 j9 [% P0 s1 b# x0 q1. Develops SAS programs to produce data listings and Case Report Form Tabulations (CRT)
1 b/ J5 s. k! A+ }- l% ~/ Y+ ^2. Builds standard tabulation datasets
- |- y3 ?+ J4 q3. Creates derived or analysis datasets : f0 ?& W; E& |
4. Develops SAS programs to implement statistical analyses to generate tables, listings and figures as specified in the statistical analysis plans5 W# ~9 l8 h9 b, ]% \
5. Performs validation of and quality assurance aspects of all SAS programming activities
4 g* N; j: t* a5 R& V6. Develops SAS programs for other needs
% Y8 f! f) H6 P5 i& D2 W) u/ H( n- K7. Consults on other statistical programming tasks, such as support for CRF design, database development, data validation plan and blinded data review.
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0 x9 T7 g: @' h! h8 sQualifications/Requirements:
* o4 S) B& G: \; h( R6 B% Z1. Excellent English communication skills, can work independently with native English speaker.
8 J# G" y* J( f$ ^+ N3 R2. Must have proficient SAS or Oracle SQL programming skills, if have neither of these two, must have a demonstrated capabilities to program in advanced languages: like C++, JAVA and/or assembly language.# C1 y( N5 t. o; b+ o
3. Must possess great interpersonal capabilities and can work with people from different cultures. Have ability to construct good relationship within a team environment.3 J" y& }- g" m3 i
4. IT background preferred. Candidates from other majors with strong records and strong intention to be a programmer analyst are also welcomed.
4 e: t- B9 ]: j9 A. ^5. Must have a bachelor degree, higher degrees are preferred.
' F3 x" h5 v* ~9 h6. Knowing drug development procedures and FDA/SFDA regulations is a plus., I' r0 c* v1 V" h
7. Oversea working experience in IT, Statistics, Math is a plus.! P; [" N, `( l6 H6 u5 `7 U: `
8. If apply for Sr. or Manager level position , must also have broad clinical trial background and have a knowledge of government regulations on drug development procedures, exempt for other levels.
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If this sounds like the role you are looking for please submit your application to: seven.shen@ppdi.com and Zibao.zhang@ppdi.com .
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We are waiting to hear from you!
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