Posted 1 year ago in Biotech/Pharmaceutical
Principal Duties and Responsibilities: 1. Plan, coordinate and produce statistical plans for PDL clinical programs throughout the life cycle of the responsible compounds.
2. Apply statistical expertise to ensure optimal clinical trial designs and statistical analysis methods.
3. Help devise data capture methods (case report forms or other) for pertinent clinical programs.
4. Create statistical analysis plan and perform analyses according to established program standard for responsible clinical programs.
5. Assist in final study report writing and ensure accurate reporting of the analysis outcomes.
6. Work with the Director of Biostatistics and the clinical development teams to standardize the statistical analyses and outputs for the responsible programs.
7. Assist/mentor/supervise junior level biostatisticians on clinical trial design and statistical analysis as needed.
8. Direct external (CRO) data management efforts, as needed.
9. Direct the activities of internal and/or external bioanalysts/SAS programmers as they pertain to the above responsibilities.
10. Attend regulatory meetings and support/defense the responsible clinical programs.
1. MA or Ph.D. in (Bio)statistics.
2. Minimum of 6-8 years experience in pharmaceutical or biotechnology industry.
3. Must have experience preparing analysis programs for clinical trials phases I-III.
4. Must have been primary statistician on at least one NDA/BLA.
5. Must have sound knowledge of statistical applications for clinical trials.
6. Excellent writing and communication skills, and knowledge and skills of programming important.
7. Strong knowledge of and experience in clinical trials design.
8. Very good knowledge of drug development regulations pertinent to trial design and statistical analysis.
· While performing the duties of this job the employee is regularly required to stand, walk, sit, talk or hear.
· Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and the ability to adjust focus.
Headquartered in Tampa, FL, with operations in all 5 regions, The Fountain Group is a Contingent Labor Resource Provider. The Fountain Group services clients directly, clients with an internal contingent labor program, and clients with an external managed service program.
The Fountain Group was founded in 2001 with the mission of providing quality resources to businesses on a contingent basis and has been providing quality individuals to National Fortune 100
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