Summary: Under general supervision, provides statistical support in the design, analysis and interpretation of preclinical and clinical studies. Reviews the statistical aspects of study protocols and reports, and prepares the assigned sections. Develops and executes statistical analysis plans, interprets the results, and generates tables, listings, and figures. May work with external partners and CROs as appropriate.
Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
1. Carries out responsibilities in accordance with the organization?s policies, procedures, and state, federal and local laws.
2. Supports the generic development of inhaled products
3. Serves as primary author or validator/QC for in vitro bioequivalence submission deliverables:
1. Statistical report
2. ANDA tables (population BE, descriptive statistics)
3. SAS transport files and corresponding ?define? documentation
4. Provides statistical support for pharmacokinetic, clinical endpoint and pharmacodynamic studies:
1. Reviews and provides statistical expertise for protocol, statistical analysis plan and clinical study report
2. Researches literature/label/approval history for appropriate endpoints, effect sizes and variability estimates needed at study design stage
3. Estimates power/sample size either through direct calculation or simulation
4. Ensures SAS transport files and corresponding documentation for ANDA submissions are in accordance with CDISC standards and/or healthy authority guidance
5. Provides ad hoc analyses, statistical consultation and trouble-shoots unexpected results
6. Suggests appropriate study designs given product characteristics and business needs
7. Performs duties of a pharmacometrician including plotting concentration-time profiles, calculating PK parameters, predicting drug concentration to estimate washout, predict steady- state PK parameters, etc.
5. For standalone outsourced statistical deliverables :
1. Reviews/QCs all CRO deliverables
2. Provides guidance on project specifications
3. Negotiates timelines and costs as appropriate
4. Serves as liaison between CRO and data lab
6. Supports research activities of the IPAC-RS Population Bioequivalence and/or Modified Chi-Square Ratio Working Groups
1. Proficiency in SAS programming, including the ability to code complex mathematical formula from literature, develop algorithms for simulation/bootstrapping and provide quality graphics
2. Ability to effectively communicate and collaborate in a cross-functional team environment with clinical, scientific and regulatory colleagues
3. Familiarity with linear models (ANOVA, mixed models) and variance component analysis
4. Experience with clinical study designs (e.g. Bioequivalence crossover designs), pharmacokinetics or analysis of in vitro data (e.g. population bioequivalence) is desirable
5. Must be motivated to remain current with statistical literature relevant to areas of application
Physical Requirements and Working Conditions: Requires the ability use office equipment such as a personal computer, copier and fax machines regularly during the course of work and to sit for extended periods
1. Bachelor?s degree in statistics or closely related discipline; Master?s preferred
2. Prior experience supporting clinical trial research
- Apply online at: http://www.hirelifescience.com/seeker_jobs.aspx?jobsID=456801&jobtitle=Biostatistician%20Sr.