This position requires statistical expertise and technical support as it relates to the design and statistical analysis of clinical oncology and autoimmune disease studies. This position will also be responsible for developing, analyzing and interpretation of study results.
Provides timely and scientifically sound statistical guidance and technical expertise to clinical development projects.
Participates in departmental and cross-functional meetings to optimize clinical study designs, endpoints, and analyze strategies.
Works closely with data management and clinical research/clinical operations personnel to develop and validate study-specific data capture activities.
Develops statistical analysis plans to meet regulatory standards, coordinates/performs data analysis and validation, and provides data interpretation.
Produces tables, figures, and listings for reporting of study results and data.
Assists in the development of study protocols, provides sample size estimates and calculations for study designs, and oversees generation of randomization schedule for complex randomization schemes.
Reviews 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.
Writes specifications for datasets, tables, figures, listings; checks consistency for both efficacy and safety analyses; performs validation of key statistical results.
Analyzes clinical trial data producing accurate results representing the outcome of the trial. Validates statistical output.
Performs statistical analysis for publication.
Provides input in preparation of study reports, with particular emphasis on the statistical methods section and works closely on study report preparation.
Collaborates with other key personnel in regard to the publication of study data.
Interacts with FDA statisticians and other external parties as required.
Guides and collaborates with CRO staff to ensure alignment with established data, analysis and quality standards.
Stays current with new developments in statistics, drug development, and regulatory guidance.
May supervise or lead other statistical or programming personnel as assigned.
Carries out direct supervisory responsibilities in accordance with the department-set goals. Responsibilities include interviewing and onboarding; employee training and development; planning, assigning, and directing work; appraising performance; rewarding and disciplining; corrective action and complaint resolution.
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.
Individual must be proficient 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.