Job Description
Responsibilities: - Position leads complex studies in study design, statistical analysis and interpretation of results with some supervision.
- This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to Health Authorities globally with some supervision.
- This position also guides contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses.
- Additionally, this position interacts with study teams, as well as statisticians and programmers at CROs.
- This position works under some supervision to solve complex study problems.
- Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review.
- Acts as main statistical contact for the assigned studies and projects.
- Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.
- Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile to create ISS, Shells, TFLs, and Ad Hoc Analysis.
- Able to attend meetings and make appropriate decisions.
- Able to prioritize multiple tasks, develop instructions and manage vendors in completing the deliverables with high quality according to timelines, and provide recommendations to improve process.
- Compliant with internal and external compliance practice to ensure integrity of work and suggest innovative approaches to improve compliances and processes.
Requirements: - MS or PhD level Statistics.
- 5-6 years Pharmaceutical and/or CRO experience.
- SAS Programming experience.
- Strong knowledge of statistical methodologies, current drug development trends, and regulatory environments.
- Excellent programming skills in SAS and working knowledge of software such as nQuery, East, etc.
- Significant knowledge of pharmacology, clinical research, and medical terminology and use it for study design and results interpretation.
- Strong analytical and problem-solving skills and able to provide guidance to lower-level biostatisticians in solving problems.
- Able to identify and investigate issues and causes independently and formulate potential solutions.
- Able to develop and execute strategic plans for drug or non-drug projects.
- Excellent oral and written communication skills.
- Working knowledge of clinical trial methodologies.
- Experience working in Phase I- III clinical trials.
- Experience in Submissions/Filings and post Submission activities.
- Work experience in Pharma/Medical Device/CRO.
Job Tags
Contract work, Work experience placement,