Clinical Research Assistant supporting clinical trials and participant engagement in obesity care at knownwell, Inc. Responsible for patient - facing activities to ensure high - quality experience.
About the role
- Senior Principal Biostatistician providing statistical expertise across therapeutic areas in clinical development. Collaborating with study teams and overseeing analysis plans for vital projects.
Responsibilities
- Lead biostatistics representation on project or study teams and provide statistical expertise.
- Define statistical methodologies, analyze data, and report results for clinical development plans.
- Train and supervise contract statisticians, ensuring quality deliverables.
- Assist in addressing statistical issues in regulatory, legal, or other challenges.
- Serve as a peer reviewer and internal consultant on broad statistical issues.
- Participate in process improvement initiatives and mentor new/junior biostatisticians.
- Conduct modeling and simulations as needed.
- Collaborate closely with study or project teams for data interpretation and reporting.
- Work with statistical programmers, data management, and vendors to deliver analysis results.
- Collaborate with medical writers to complete study reports and manuscripts.
- Supervise FSP statisticians in assigned tasks.
Requirements
- PhD in Biostatistics or equivalent with a minimum of 5+ years relevant work experience in the pharmaceutical/biotech industry.
- Thorough understanding of statistical principles and clinical trial methodology.
- Ability to provide technical solutions to a wide range of difficult problems.
- Conversant with R, SAS, or other statistical software programming languages.
- Working knowledge of regulatory guidelines related to statistical analysis.
- Strong ability to manage multiple projects and conflicting priorities.
- Excellent written and verbal communication skills.
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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