Responsible for supporting the planning, oversight and implementation of statistical analysis for assigned clinical trials as the statistical lead, spanning from the design and development of clinical trial documents and selection through the oversight of protocol implementation, data analysis and assembly of final study documents.
ESSENTIAL DUTIES & RESPONSIBILITIES:
- Leads the statistical strategy across a development program.
- Selects appropriate statistical methods for analysis of clinical study data. Liaises with project teams to communicate biostatistics approach for clinical studies.
- Calculates sample sizes/power for proposed studies, for alternative designs, and evaluates the advantages/disadvantages and timelines for various scenarios.
- Manages work of biostatistics vendors and contractors for assigned studies.
- Leads the study teams in the review and discussion of analysis plans.
- Writes and/or approves analysis plans, statistical sections of protocols and reports, statistical sections of abstracts, publications and presentations, and statistical requirements for data collection.
- Manages biostatistics and programming deliverables for CSRs and submission documents from CROs for assigned studies.
- Key member of submissions team.
- Responsible for interacting with Health Authority personnel on statistical questions.
- Consults with project teams on the interpretation of efficacy and safety results, working closely with study clinicians.
- Provides technical oversight of contracts supporting biometric activities.
- Provides project management expertise, as needed, to ensure quality and timely completion of project milestones.
- Master’s Degree or higher in Statistics, Biostatistics, Mathematics, or closely related field.
- Minimum seven (7) years of experience in a drug-development environment.
- Knowledge of pharmaceutical and regulatory requirements, procedures, and policies.
- Knowledge of GCP and ICH guidance related to statistical principles and clinical trials.
- Proficiency in SAS and nQuery software packages. Knowledge of CDISC requirements.
- Demonstrated ability to program and oversee work performed by programming staff/contractors or vendors.
- Excellent computer skills; strong verbal and written communication skills.
- Ability to competently manage a heavy workload and multiple competing priorities, switching priorities quickly as needs change. Must be comfortable working in a fast-paced environment.
- May travel up to 20%.
The above description is intended to describe the general nature of the job that may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.
Heron is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity.