Kerry Go
- Role
- Deputy Director, Biostatistics at Sanofi
- Location
- Bethlehem, PA, US
- LinkedIn followers
- 500 followers
About Kerry Go
Experienced hands-on biostatistician with 30 years of experience in a top ten company in…
Experience
Deputy Director, Biostatistics
Jul 1997 — Present
Assist in recruiting and scheduling of statistical and programming staff. • Oversee and review stat and prog work, e.g, protocols, statistical analysis plans (SAPs), and CSRs. • Organized programming efforts to complete Items 10 and 11 for 3 eBLA submissions. • Lead statistician on projects in Phases I, II, and IV, including the first US approved pandemic flu vaccine (H5N1) and the novel H1N1 vaccine. These trials cover the following areas: pediatric vaccines, flu vaccines, meningitis vaccine, vector-borne diseases, and travel vaccines. • Work closely with medical, reg affairs, and proj planning during all phases of studies to provide stat consulting, including clin dev plan development, sample size calculation, protocol development, and SAP creation. • Lead team to standardize descriptive safety tables, and participate on teams to standardize immunogenicity, disposition, and demographic tables and listings, rules for handling missing data, presentation of numbers, and output file formats. • Developed course “Statistics for Non-statisticians” • Develop statistical SOPs and SWIs, and standards for statistical analysis plans, randomization, descriptive tables, handling missing data, outsourcing statistical work, presentation of numbers, and output file formats. • Write SAS macros to compute power and sample size. • SAS site admin; work with IS to evaluate software.
Skills
- Sas
- Sop
- Clinical Study Design
- Clinical Data Management
- Medicine
- Regulatory Affairs
- Clinical Trials
- CRO
- Standard Operating Procedure (Sop)
- Statistics
- Biostatistics
- Fda
- Clinical Research
- Regulatory Submissions
- Sas Programming
- Immunology
- Clinical Development
- Pharmaceutical Industry
- Protocol
- Edc
- Gcp
- Vaccines
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