[jsfg_cinti] Job Posting: Biostatistian

The following job opportunity has been posted to the JSFG E-mail Mailing Li=
st.

Date: 02/14/07
JobTitle: Biostatistian
JobClass: Engineering/Technical
JobDescript: Description:=20
=EF=BF=BD Provide statistical expertise and leadership in product developme=
nt=20
=EF=BF=BD Develop and implement SOPs/systems for biostatistical responsibil=
ities; integrating with data management and clinical operations systems=20
=EF=BF=BD Provide statistical strategy and input into clinical protocols an=
d CRFs=20
=EF=BF=BD Critically review Data Management Plans and annotated CRFs=20
=EF=BF=BD Work cooperatively with Data Management staff to ensure seamless =
transition of database output to SAS/statistical datasets; ensure employmen=
t of CDISC standards; ensure validated statistical output=20
=EF=BF=BD Prepare Statistical Analysis Plans and data dictionaries for anal=
ysis datasets=20
=EF=BF=BD Program and QC Tables, Listings and Graphs/Figures; prepare stati=
stical output of study data including integrated statistical summaries (ISS=
, ISE)=20
=EF=BF=BD Interpret statistical results; provide statistical consultation; =
communicate and represent results within the company and at regulatory meet=
ings; draft statistical methods sections of reports, summaries and manuscri=
pts=20
=EF=BF=BD Provide statistical support to Preclinical/R&D staff as needed=20
=EF=BF=BD Perform tasks as assigned by supervisory management=20

Location: Woburn, MA=20
Requirements_Qualif: =EF=BF=BD Statistics PhD with 3 years of pharma/biotec=
h experience or statistics MS with 8 years of pharma/biotech experience=20
=EF=BF=BD Proficient in SAS and clinical data processing=20
=EF=BF=BD Extensive knowledge of FDA & ICH statistical regulatory standards=
=20
=EF=BF=BD Experience with CTD formatted NDA/BLA submissions=20
=EF=BF=BD Excellent written and verbal skills, fluency in English=20
=EF=BF=BD Ability to prioritize and problem-solve=20
=EF=BF=BD Strong interpersonal skills; ability to work cooperatively in a t=
eam environment
WorkType: Salaried
Travel: No
PositionState: New
SalaryRange: $$70K - $110K
HowApply_Email: Yes
Company: Work Wonders Staffing
Person_Requesting_Profiles: Mike Wilmarth
Contact_StreetAddress: 4107 East Woodstock Rd
Contact_City: Cave Creek
Contact_State: AZ
Contact_ZipCode: 85331
Contact_WorkPhone: 480-282-4254
Contact_FAX:=20
email: mikewilmarth@xxxxxxxxx
Industry:=20
Comments:=20




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