Essential Duties & Responsibilities:
- Contributes to study level tasks from statistics perspective: selection of study design, selection of end points to meet research objectives, sample size and power calculation, and analyses methods.
- Develops or review SAPs, TLF shell and specification, and review CRF's and other study documentations
- Performs ad hoc statistical analyses, including the statistical programming, for assigned studies; interprets data and provides statistical input to clinical protocols, Clinical Study Reports (CSR).
- Lead and/or manage both in-house and CRO activities related to statistical analysis, programming and data management.
- Performs simulations to create mock analyses. Proposes new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results.
- Interacts with staff from other operational groups (clinical research, clinical OPs, marketing and preclinical).
- Develops biostatistics and data management SOP's.
- Provides effective guidance and communicates to CRO staff in the production of tables, figures, and listings.
- Reviews and validates analysis data sets, tables, figures, and listings.
- Reviews database design, CRF's, and edit checks.
- Attends FDA advisory committee meeting.
- Reviews and prepares Integrated Safety (ISS) and Integrated Summary Efficacy (ISE).
- Reviews CDISC/SDTM and DEFINE.XML
- Attends Operations meetings, keeps up-to-date on project issues companywide, and keeps Director informed of project issues.
- Works under limited supervision.
- Assists with other duties as assigned.
- Interacts with clients as needed for project and/or relationship management.
Supervisory Responsibilities:
- Provides oversight to the data capture and management, and database requirements.
Knowledge and Other Qualifications:
- PhD. with 6+ plus years of experience or MS in Biostatistics with 8+ years of experience in pharmaceutical/CRO, including significant interactions with regulatory bodies and experience in central nervous system indication preferred.
- Experienced in NDA activities as a key contributor from statistics perspective and direct involvement in regulatory interaction.
- Broad knowledge and superior understanding of advanced statistical concepts and techniques with experience in adaptive designs, longitudinal data analysis, handling missing data using pattern mixture models, sensitivity analysis.
- Fluent in SAS data step programming including SAS macro, familiarity with other packages (e.g., nQuery Advisor, R).
- Familiarity with ICH guideline and FDA other regulatory authority guidance.
- Excellent written and oral communication skills including grammatical/technical writing skills.
- Excellent attention and accuracy with details.
- Familiarity with statistical methods that apply to Phase I-IV clinical trials.
- Strong organizational skills.
- Ability to solve moderately complex problems (identify, propose & implement
- solutions).
- Ability to work in team situations.
- Demonstrated strong individual initiative.
- Ability to effectively manage multiple tasks and projects.
- Ability to lead and co-ordinate the work of small teams.
- Ability to work in a fully self-directed manner
Other Characteristics:
- Authorized to legally work in the United States without visa sponsorship.
- Ability to consistently exhibit Values in interactions with employees at all levels of the organization, vendors, customers and others.
- Ability to work independently and as part of a team.
- Ability to maintain high ethical standards of integrity and quality.
- Capable of being innovative and dynamic in approach to work.
