Associate Director Biostatistics

Location: Rockville, Maryland
Job Type: Blijvend
Specialisation: Life Sciences
Salary: Negotiable
Reference: BBBH1733_1631119226
Contact: Jessica Charles
Email: email Jessica
I've partnered with an award winning medium sized biopharmaceutical company based in Rockville who have extensive experience in the development and commercialisation of CNS products with a number of products already in the market.


They're looking for an experienced Biostatistician to join their growing team and work alongside the VP on both the day to day running and direction of the department. You'll be responsible for directing the biostatistics activities for clinical studies from trial design, execution, analysis, and data interpretation, alongside leading in-house and CRO activities related to statistical analysis, programming and data management.


Role: Associate Director, Biostatistics.


Responsibilities:
Develops biostatistics and data management SOP's.
Provides effective guidance and communicates to CRO staff in the production of tables, figures, and listings.
Reviews and validates analysis data sets, tables, figures, and listings.
Reviews database design, CRF's, and edit checks.
Attends FDA advisory committee meeting.
Reviews and prepares Integrated Safety (ISS) and Integrated Summary Efficacy (ISE).
Reviews CDISC/SDTM and DEFINE.XML.


Requirements:
Ph.D. with 6+ plus years of experience /MS in Biostatistics with 8+
Experience in the pharmaceutical/CRO setting
Experienced in NDA activities as a key contributor from statistics perspective and direct involvement in regulatory interaction.
Broad knowledge and superior understanding of advanced statistical concepts and techniques with experience in adaptive designs, longitudinal data analysis, handling missing data using pattern mixture models, sensitivity analysis.
Proficient in SAS programming including SAS macro, and familiarity with other packages (e.g., nQuery Advisor, R).
Familiarity with ICH guideline and FDA other regulatory authority guidance.
Familiarity with statistical methods that apply to Phase I-IV clinical trials.
Experience of working within CNS


If this sounds of interest, please reach out to me at 01737 236729 /