Date: Wed, 21 Feb 2001 23:18:30 -0800
Reply-To: "Gary F. Leatham" <gfleatham@strategicresources.com>
Sender: "SAS(r) Discussion" <SAS-L@LISTSERV.UGA.EDU>
From: "Gary F. Leatham" <gfleatham@STRATEGICRESOURCES.COM>
Organization: Strategic Resources
Subject: Networking Reguest -- Great opportunities for the right people
(SAS Biostatisticians & Clinical Medical Writers)
Content-Type: multipart/alternative;
Dear Colleagues,
Experienced proven Biostatisticians and Medical Writers are needed in the Clinical Testing of Pharmaceuticals (see specifics below). These are permanent positions, in cutting-edge Corporations, with good/excellent salaries and benefits. All are in beautiful West Coastal cities ... near Seattle, WA, Irvine, CA and/or the East San Francisco Bay areas. Their purpose is to gather the data necessary to register therapeutics, and file final documentation with the FDA and International Regulatory Agencies.
Your help is much appreciated in suggesting promising Colleagues, who deserve a break.
These are great opportunities for the right people ... and they are available now!
Thank you in advance!
Gary F. Leatham, Ph.D.
Strategic Resources
Bellevue, WA
_________________________________________________________
Location: Near Seattle, WA
Biostatistician(s) (2)
Working comfortably on a multidisciplinary team, you'll collaborate with the Senior Biostatistician in developing and reviewing statistical sections of protocols, analysis plans, and statistical analyses. You'll also help ensure that the data elements needed for planned analyses are captured in the CRFs and that appropriate edit checks are planned. Further, we'll rely on you to define primary variables for inclusion in analysis datasets; check analysis datasets, tables and listings produced by CROs; write programs in SAS to analyze data and generate table listings and figures that summarize data and analysis results; and summarize results in written form for inclusion in the Final Study report and for submission to regulatory authorities. This position requires a Ph.D. or equivalent in Statistics or Biostatistics, proficiency in SAS, including SAS/STAT and SAS/GRAPH, and 2+ years experience programming in clinical trials. Attention to detail, organization skills and the ability to provide ongoing information to supervisors and peers are essential. The job will include up to 20% travel.
-- Associated Writers Needed in Near Future --
_________________________________________________________
Location: Near Irvine, CA
Medical Writer & Biostatisticians (3) - Group Opportunity
Work for a solid prestigious company, whose is further expanding their already substantial research program, on a beautiful corporate campus, with excellent salary and benefits. Located in sunny, Coastal California, south of Los Angeles. This is a proven profitable company.
Medical Writing Project Manager
We currently have an opportunity for a talented and motivated medical writer/project manager to join an expanding medical writing department. Requires a BS/BA degree (minimum) in a science related field (prefer M.S. or Ph.D.) and 3+ years of direct pharmaceutical experience preparing clinical documents for submission to domestic and foreign regulatory authorities. Such documents include final submission documents, clinical study reports, IND NDA/PLA clinical sections, investigator brochures, patient synopsis, and study protocols, and annual progress reports. Must have experience reviewing and providing appropriate feedback on documents prepared by independent consultants, contract research organizations, and internal personnel. Require strong analytical skills, the ability to interpret and present complex data clearly, experience in several therapeutic areas including pharmacology, dermatology, and neurology, the ability to work on more than one document at a time. Rigorous attention to accuracy, editorial style, and timelines are also required.
Biostatisticians (3): Pre-Clinical, Clinical & BioStat Group Manager
Need three top-notch statisticians, having experience in major pharmaceutical companies, to capitalize on the expansion of a major R&D program. Requirements include the following:
a.. Ph.D. in Statistics/Biostatistics
b.. NDA experience with major pharmaceutical companies.
c.. Minimum 4-5 years experience in drug industry
d.. Good understanding of ICH guidelines and FDA/EMEA experience
e.. Skillful project management and communication abilities
f.. Pre-Clinical position: pre/non-clinical experience
g.. Clinical position: clinical experience
h.. Manager position: 7+ years clinical experience & some leadership experience
_________________________________________________________
Location: San Francisco (East Bay), CA
Senior Medical Writer & Clinical Medical Writer (2 Positions)
The Medical Writer will be responsible for using protocols, case report forms, data tables and data listings and data figures as source documents to write and edit (using the ICH format where appropriate) the following types of documents: final report, patient synopsis, investigators brochure, IND, NDA, study protocol, and annual progress report. The duties of the Medical Writer will also include the following: establish timelines with the project team for the writing tasks, obtain internal (and external, when appropriate) document review, incorporate reviewer comments, finalize the document and obtaining final signoff for the document. The medical Writer may also prepare scientific manuscripts to be submitted for publication (using the format required by the target journal). This is a medical biotechnology group with excellent growth potential.
Responsibilities - Essential Job Functions:
Using protocols, case report forms, data tables and data listings and data figures as source documents to write and edit (using the ICH format where appropriate) the following types of documents:
a.. Final reports
b.. Patient synopses
c.. Investigators brochures
d.. NDAs
e.. INDs
f.. Study protocols
g.. Annual progress reports
The duties of the Medical Writer will also include the following:
a.. Establish timelines with the project team for the writing tasks
b.. Obtain internal (and external, when appropriate) document review
c.. Incorporate reviewer comments
d.. Finalize the document
e.. Obtaining final signoff for the document
f.. The medical Writer may also prepare: Scientific manuscripts to be submitted for publication (using the format required by the target journal)
Position Requirements:
Education/employment history:
a.. University graduate with a bachelors degree in science, communications, English or equivalent
b.. 5+ years experience in medical writing for a pharmaceutical, biotechnology or contract research company or university medical center (i.e., clinical documentation experience).
Required experience:
Using protocols, case report forms, data tables and data listings and data figures as source documents to write and edit (using the ICH format where appropriate) the following types of documents:
a.. Final reports
b.. Investigators brochures
c.. Good writing sample portfolio
Ideal experience:
a.. Final reports
b.. Patient synopses
c.. Investigators brochures
d.. NDAs
e.. INDs
f.. Study protocols
g.. Annual progress reports
h.. Scientific manuscripts to be submitted for publication (using the format required by the target journal)
_________________________________________________________
To Apply for All Positions:
E-mail your resume in MS-Word format, with a separate overview summary
page, giving 'bullet points' (5 to 10), outlining your key features and strengths,
which I will use to help present you.
Gary
Gary F. Leatham, Ph.D.
Executive Search Principal - Life Sciences, Biotechnology and Engineering
Strategic Resources
14645 Bel-Red Road, Suite #201
Bellevue, WA 98007
Voice 425-688-1151 Ext.#107
Fax 425-688-1272
gfleatham@strategicresources.com
http://www.strategicresources.com/
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