Job Locations US-NJ-Morris Plains
Posted Date 4 months ago(1/18/2018 11:06 AM)
Job ID 2018-1049
# of Openings 1
We are seeking a Senior Biostatistician to provide statistical expertise and technical support as it relates to the design and statistical analysis of clinical oncology and autoimmune disease studies. Develop and perform analysis and interpretation of study results.
* Provide timely and scientifically sound statistical guidance and technical expertise to clinical development projects.
* Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies.
* Work closely with data management and clinical research/clinical operations personnel to develop and validate study-specific data capture activities.
* Develop statistical analysis plans to meet regulatory standards, coordinate and perform data analysis and validation, and provide data interpretation.
* Produce tables, figures, and listings for reporting of study results and data.
* Assist in the development of study protocols, provide sample size estimates and calculations for study designs, and oversee generation of randomization schedule for complex randomization schemes.
* Review study protocols, CRFs, data validation specifications, and other study-related documents in order to ensure correctness of statistical representation of data and results, and collection of required data.
* Write specifications for datasets, tables, figures, listings, and consistency checks for both efficacy and safety analyses; perform validation of key statistical results.
* Analyze clinical trial data producing accurate results representing the outcome of the trial. Validate statistical output.
* Perform statistical analysis for publication.
* Provide input in preparation of study reports, with particular emphasis on the statistical methods section, and work closely on study report preparation.
* Collaborate with other key personnel in regard to the publication of study data.
* Interact with FDA statisticians and other external parties as required.
* Guide and collaborate with CRO staff to ensure alignment with established data, analysis, and quality standards.
* Stay current with new developments in statistics, drug development, and regulatory guidance.
* May supervise or lead other statistical or programming personnel as assigned.
* PhD degree in biostatistics, statistics, mathematics, or related discipline with 5 years work experience in statistical analysis of clinical trials data OR a MS degree in biostatistics, statistics, mathematics, or related discipline with 7 years work experience in statistical analysis of clinical trials data.
* Proficiency in SAS statistical programming. Must possess strong working knowledge of Microsoft SQL programming and SAS software system including, SAS/BASE, SAS/STAT, SAS/SQL, SAS/ODBC, SAS/ACCESS and SAS/GRAPH. Knowledge of other statistical and data management software/packages a plus.
* Comprehensive knowledge of statistical methodology in design and analysis, and regulatory requirements relating to clinical development of drugs and biologics; oncology and autoimmune disease experience is highly preferred.
* Experience supporting publication of analysis results (e.g., abstracts, posters, manuscripts).
* Extensive knowledge of industry standards, such as GCP and ICH guidelines, CDISC standards and models, 21 CFR Part 11, and FDA guidelines.
* Familiarity with pharmacokinetic (PK) / pharmacodynamics (PD) data a plus.
* Experience interacting (directly or indirectly) with the FDA.
* Excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials are required.
* Effective interpersonal skills and problem solving capabilities. Strong project management and mentoring/leadership skills.
* Excellent organizational and time management skills with the ability to work independently and coordinate workload, under pressure, and in a team environment to meet established deadlines.
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Website : http://www.immunomedics.com/