Proclinical is seeking a Senior Statistician to collaborate with pharmaceutical clinical teams and provide statistical expertise in clinical drug development programs. This role offers diverse responsibilities, client interaction, and opportunities for professional growth. You will act as a key contributor to study designs, data analysis, and regulatory submissions while mentoring junior team members and fostering collaborative relationships.
1. Responsibilities:
2. Serve as the lead statistician for one or more clinical studies or programs.
3. Provide input on study design, efficacy and safety parameters, and planned statistical analyses.
4. Perform sample size calculations and study design simulations.
5. Author and review Statistical Analysis Plans (SAPs).
6. Oversee statistical deliverables from assigned CROs.
7. Participate in protocol development, data review meetings, and study-related activities.
8. Conduct exploratory analyses and contribute to clinical study reports.
9. Review and provide input on regulatory documents and publications.
10. Mentor junior statisticians and support their development.
11. Build effective relationships with pharmaceutical study teams, including programmers, clinicians, and project managers.
12. Communicate study designs, analysis methods, and trial results effectively.
13. Lead study teams and present updates internally and at client meetings.
Key Skills and Requirements:
14. Strong understanding of the clinical drug development process, study designs, and endpoints.
15. Familiarity with industry standards, ICH guidelines, and regulatory requirements.
16. Proficiency in statistical software such as SAS or R.
17. Excellent interpersonal, teamwork, and communication skills.
18. Ability to manage competing deliverables with attention to detail and problem-solving skills.
19. Self-motivated and capable of working independently or as part of a team.