Senior Statistician

POSITION SUMMARY:

 

The Sr. Statistician will provide critical support to all elements of the development process for novel vaccines for the prevention of TB.  This position is in the Clinical Development Department but will be responsible for assisting all Aeras departments in the development, implementation, and analysis of all data-driven research needs, including study design and analysis, strategic planning and statistical assessment of immunological assays.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

 

· Assists clinical team in designing all AERAS-sponsored clinical trials and prepares all statistical sections of clinical protocols using appropriate statistical methodology for the specific trial, including selection of study design, sample size, and analyses.

· Works with the clinical data management and SAS programming team members to develop all statistical tables and listings for interim analyses and final study reports.

· Reviews database design, CRF’s, and edit checks.

· Prepares statistical analysis plans.

· Reviews and validates all tables and statistical output for preparation of study reports.

· Prepares statistical sections for relevant background documents for EU, Africa, and U.S. regulatory agencies.

· Works with the Immunology department to develop guidelines for human assay qualification and validation protocols, and prepares study reports for assay validation.

· Assists the Epidemiology department in the analysis of long-term cohort studies.

· Helps the Manufacturing and QA departments in reviewing QA guidelines and designing SOPs.

· Works with the Animal Studies department to design and analyze animal challenge studies.

 

QUALIFICATIONS AND REQUIREMENTS:

 Master’s Degree in Statistics, Biostatistics, or related discipline; Ph.D. preferred. 6+ years experience with drug development statistical analysis with a biotechnology or pharmaceutical company.Proficiency in SAS programming.Knowledge of experimental design, power calculations, survival analysis, and linear models.Familiarity with current ICH guidances pertinent to clinical development. Previous experience in EU regulatory submissions a plus.Designs of experiments (DOE) and/or media development a plus.Excellent oral and written communication skills.Proven ability to coordinate multi-disciplinary project teams.

 

Aeras Global TB Vaccine Foundation is an Equal Opportunity Employer. M/F/D/V