Global specialty pharmaceutical/biotech company that develops, manufactures, markets and distributes specialty pharmaceutical products. Areas of focus include a wide range of therapeutic franchises such as rare disease specialty areas like neurology, oncology, rheumatology, pulmonology; immunology and central nervous system drugs. The company’s core strengths include the acquisition and management of highly regulated materials; regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities.
- Provides statistically sound experimental design, including sizing and data analysis input to meet project objectives and FDA statistical requirements as appropriate.
- Writes statistical analysis plans and statistical sections of protocols.
- Reviews protocols, case report forms, data management plans, sample size estimates, randomization schedules, clinical study reports and sections of regulatory submissions; and performs statistical analysis in support of product regulatory submissions.
- Assures acceptability and scientific integrity of data collection and analysis through appropriate application of statistical principles and methodology, and is able to argue logically in support of study results and conclusions.
- Develops statistical analysis strategies and selects appropriate methodologies for research studies involving pharmaceuticals, contrast imaging agents, and medical devices.
- Applies statistical theory and analysis methods to data to ensure a sound scientific basis for product performance claims.
- Functions at discretionary level of autonomy and without appreciable direction as deemed appropriate by Director of Biostatistics.
- Manages departmental interactions with external resources such as Contract Research Organizations and statistical consultants.
- BS degree with MS degree in Business Mathematics, Economics, Statistics, Engineering or Quantitative Field required; PhD preferred.
- A minimum of 6 years experience required in the design, analysis, and reporting of clinical trials for regulatory submissions. Participation as statistical lead in meetings with regulatory authorities preferred.
- Course work and experience with Health Economics and Outcomes Research studies preferred.
- Demonstrated ability to recommend plans for research design, particularly in the areas of observational studies or studies of comparative effectiveness and safety.
- Strong working knowledge of relevant statistical software and substantial experience with SAS including graphics.
- Experience in managing biostatistics and data management CROs a plus. Sound knowledge of theoretical and applied statistics and the ability to be innovative and apply relevant, current and novel statistical concepts.
- Strong proficiency in SAS programming, including CDISC (STDM, ADAM), and strong working knowledge of relevant statistical software (e.g. R, StatXact, SigmaPlot, etc.).
- Excellent attention to detail, organizational and time management skills to prioritize and coordinate workload with minimal supervision.
- Effectively manage biostatistics and data management vendors/CROs and other professional staff as necessary. Presentation skills and comfort with presentations to non-statistical audiences.
- High degree of knowledge about and proficiency in SAS programming. Expertise in biostatistical methodologies common to clinical trials. Knowledge of relevant regulatory guidance (ICH E-series, EMEA Points to Consider).
- Ability to accomplish objectives in a matrix organization including external contributors.
up to $180K+ plus 15% Annual Bonus + LTI (Long Term Incentive)
New Jersey/NY Area
Yes, full package
ZG - 4344