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国内最大CRO公司,诚聘Sr. SAS Programmer6 N& C6 f* T, h9 H9 m
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有兴趣者请联系 yujie.ma@excel-cro.com$ p, E7 K5 h! r8 F, ~0 e" D+ E' I
& B/ ?% P1 y+ `4 @* ~: G6 g% cJOB DESCRIPTION FOR SENIOR SAS PROGRAMMER% y2 l! ]0 A. S% A$ s5 M, {
Performs all SAS programming tasks for a given clinical study or studies involving drugs,0 B$ d C+ l3 l) Q3 l0 V1 d; n) C
biologics and medical devices, acts as the primary point of contact for SAS programming2 [7 e0 H1 b; ?3 a# O5 |, m
activities for a given clinical study or studies and ensures adherence to guidelines,5 _! N7 M( w3 r5 s; A4 i& z6 C0 X
methodology and SOPs for software development in accordance with FDA, ICH, GCP and7 N. }0 H5 z7 M) K( P/ c% ~+ x
SDLC methodology; and provides technical support to the programming team. y/ O+ f0 ]1 a, i6 t
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Responsibilities+ }% s$ ]) B& U
􀂾 Develops SAS programs to produce data listings and Case Report Form Tabulations
8 i+ V3 N& l* |5 x7 ^( P) T, O$ |8 F' G(CRT) as by domain or by subject! X4 P7 y3 V8 r. ^2 H' K
􀂾 Builds standard tabulation datasets according to certain industry standard or the client’s5 K) C+ a% r! Z4 B$ ?5 g- F# _
requirements
- H- @, x# N! K5 U6 R5 t􀂾 Creates derived or analysis datasets according to certain industry standard or the client’s" Q- ?; z; E1 h5 E% q8 }. D
requirements based on the statistical analysis plan2 G0 t5 w9 W& m/ a/ j
􀂾 Reviews the standard tabulation datasets and/or analysis dataset development
" W1 X- l) `# Fspecifications and SAS programs created by other SAS programmer(s)
# I8 m; p5 Z' j􀂾 Develops SAS programs to implement statistical analyses and generate tables, listings" I! T4 I" R$ C; M
and figures as specified in the statistical analysis plans4 A7 |1 n( v" t* [( \; j
􀂾 Performs validation of and quality assurance aspects of all SAS programming activities
, Z6 S) q0 W9 t: D" f7 A1 H􀂾 Supports for regulatory submission (e.g. NDA and PMA) including submission datasets- @% d3 X. E" a' ]5 Z, c8 Z
preparation
% }7 s% {6 g/ N" ?! @􀂾 Develops SAS programs for other needs
3 w& h) g! ]! s% T0 I􀂾 Represents SAS programming team at project team meetings and provides updates to
; p: C! u6 J k* K. v6 _/ Lproject team on status of tasks& d0 m. M9 [% y; u6 [
􀂾 Communicates with project team members such as Project Biostatistician, Data Manager,. W2 M9 A7 m! d9 V
and Project Manager regarding project issues
5 d/ |! S' i c" N0 C􀂾 Communicates with client regarding SAS programming issues
6 g9 }( `* b* |+ ~􀂾 Ensures integrity of all systems by preserving security and following change control
7 i6 S. S1 F2 N( M: z( m+ F3 oprocedures0 d5 c& i- r0 m4 X1 Z' T( k
􀂾 Participates in department level applications such as SAS Macro Library Development
) a; X; a( t# {7 [􀂾 Consults on other statistical programming tasks, such as support for CRF design,
: T7 l2 k9 ^8 cdatabase development, data validation plan and blinded data review/ {6 o1 @% ~) ]. E: g
􀂾 Consults on SAS program design strategies and provides technical support to
9 Z. l2 G+ g; f8 jprogramming team
: r. X- \6 N+ Z2 _: o􀂾 Mentors and trains low level biostatisticians and new colleagues8 c. H4 P1 V% w' G' G
􀂾 Performs other duties assigned by supervisor
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) I8 n- D2 X1 P+ ?: w' I. }$ UQualifications7 y' i4 g9 |# y9 {; _3 h8 I
􀂾 Bachelor degree in a scientific or technical area (statistics or related subjects is preferred);) L) b- o0 r$ i0 W
An advanced scientific degree is desirable8 @' ^7 ^! W7 E2 L, n
􀂾 Knowledge of programming methodology; a high degree of skills in the management and
2 n: {6 P. u* D8 E% _: Vresolution of SAS programming issues
" K0 V5 t( ~5 I! \ r* N􀂾 At least 3 years (for bachelor) or 2 years (for master or above) experience with Base SAS7 L5 \; Q' p7 b3 W: c6 A# a* s2 a' b
(data step programming), SAS/SQL, SAS/MACRO, SAS/ODS, SAS/GRAPH,
- g# H' C0 E& ]! E+ ^SAS/ACCESS and SAS/STAT. ISS/ISE experience is a plus
4 n d* P5 o9 {/ q7 F) Q ^􀂾 Experience with the CDISC data standards and clinical database setup is preferred' [ P* A& c) J
􀂾 Experience of international drug development in a multicultural environment is a plus2 o( ]8 }, V E
􀂾 Ability to deal with sensitive inquiries or complaints from clients or potential clients and$ h1 ?+ c1 ]+ A: n% L$ K
to protect confidentiality! V0 t7 f4 B7 a; p/ g f i2 \2 h
􀂾 Demonstration of ethical leadership skills and exhibit high moral character so as to foster' W7 C3 ?0 G5 b: v7 t I/ ^
respect for ethnic and religious diversity and support equal opportunity for all employees+ f: D% ]0 C7 j& n1 g! Z
based on demonstrated ability and to exhibit a high degree of skills in the management; p7 [( e2 ]7 ? A1 d* j2 w9 x
and resolution of conflict
P7 p1 x) v3 }􀂾 Knowledgeable in all aspects of the drug agencies (e.g. FDA) regulations and
( y; U: n; B% K9 Q% P% U5 Hrequirements governing the conduct of drug, biologic and device studies including, but
& a. b' ]0 [! J* V# anot limited to, GCP and ICH requirements
/ }8 [5 |" Y, ?0 V) m􀂾 Excellent communication and interpersonal skills" l+ q# X6 b6 E1 C
􀂾 Able to make effective presentations in public settings
# V9 R m B8 q6 \7 G. h& k% f􀂾 Proficient working in a PC/Windows environment
" Z7 V l; \; o􀂾 A good command of English language if one’s native language is not English |
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