My manager asked me to post this position to our CDISC newsgroup.
We really need someone who has been through at least one E-Submission to the FDA.
Thanks.
Elaine Dempsey
Senior Statistical Analyst/Programmer
Talecris Biotherapeutics
P.O. Box 110526
79 TW Alexander Drive
4101 Research Commons
Research Triangle Park, NC 27709
(919) 316-6612 - phone
(919) 316-6352 - fax
"The greatness of a nation and its moral progress can be judged by the way its animals are treated." - Mahatma Gandhi
Company:
Talecris Biotherapeutics
Location:
Research Triangle Park, NC 27709
Salary/Wage:
Competitive Salary, Benefits, Profit Sharing and Bonus Potential
Status:
Full Time, Employee
Job Category:
Biotechnology and Pharmaceutical
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| With an unwavering commitment to innovation, Talecris has been able to lead the global biologics industry with outstanding products that improve patient lives, as well as recognized strengths in new product research and development, pathogen safety research, and manufacturing applications. However, at the heart of our success is the innovative spirit and expertise of our employees.
A career at Talecris Biotherapeutics means more than just executing scientific processes day in and day out. It means understanding the true needs of our patients and working to develop and manufacture drugs that improve their quality of care. A highly stimulating scientific environment is maintained through interaction and collaboration with academic institutions, regular participation in scientific congresses, and patient association meetings.
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| Senior Clinical Programmer- Electronic Submissions
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Talecris Biotherapeutics, with sales in excess of $1 Billion, is a new company proud to inherit a legacy of more than 60 years of providing life-saving and life-sustaining plasma-derived therapeutic proteins.
As a team member in Clinical Operations, Medical Affairs department, the senior clinical programmer will provide the clinical programming support, data management support, electronic submission support, and the statistical programming support to all assigned Talecris clinical trials. The core responsibilities will include working with the regulatory group in providing support with submission of electronic datasets (CRTs) and/or CRFs according to the regulatory requirement; participating in the review of data set structures, edit checks, EDC specifications, and other data management related documents; generating statistical analyses (tables, listings, and figures) using SAS and other software; and acting as an integral member of a clinical project team.
Major decisions include choosing the best database structure to support the electronic submission that is appropriate for the regulatory agencies and choosing the appropriate software to accomplish this. Different agencies may require different structures.
This position reports to the Principal Statistician in Clinical Operations, Medical Affairs. He/she must be able to work independently or as a team member on assigned projects. The incumbent will spend approximately 50% of his/her time in supporting the regulatory group with electronic dataset preparation and the rest in supporting the Biometry group in clinical data programming / review, and statistical programming / review.
Minimum requirements for this position are a B.A./B.S. degree in statistics or similar discipline. At least 5 years experience in programming and analyzing the clinical trial data in clinical research organization (CRO), pharmaceutical, or biotechnology industries. Experience with electronic submissions. Good understanding of the FDA and other agency requirements of electronic clinical data submission. Excellent knowledge of SAS, including SAS macro language, data manipulation techniques, data reporting procedures (PROC REPORT, ODS), and statistical procedures (e.g., PROC FREQ, PROC UNIVARIATE, PROC GLM, PROC MIXED). Familiar with the general clinical trial data flow and data management activities. Srong organizational/ coordinating skills. Good analytical skills. Strong verbal and written communication skills. Ability to multitask and prioritize work. Knowledge of database and data structur
e of the clinical data.
Please forward your resume as a text or word attachment to michael.daniel@... with the job reference code IMBR-Clinical Programmer on the subject line. We do not accept phone calls or agency referrals. For more information, please visit our web site at www.talecris.com Talecris Biot
herapeutics offers a competitive compensation and benefits package including defined contribution pension plan and a deferred profit sharing plan. All benefits take effect day one of employment. Talecris is proud of its work/life/balance initiatives and its generous tuition reimbursement program. We have the expertise, resources and established business infrastructure to develop, manufacture and market biotechnology products internationally. An Equal Opportunity Employer M/F/D/V, |
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