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About the role
Key responsibilities & impact- Work with cross-functional teams to articulate drug development questions and assess endpoint feasibility
- Frame statistical approaches and design clinical experiments and interventional studies
- Generate and analyze clinical trial data and support interpretation and decision-making
- Co-author clinical study protocols and statistical analysis plans
- Perform statistical analyses for interim and final reports
- Develop and deliver training to non-statistical colleagues
- Collaborate on new infrastructure and processes
- Participate in professional associations, conferences, and publications to influence the pharmaceutical industry and regulatory environment
- Interact with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical Scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials
- Determine appropriate statistical methodologies and evaluate software for planned analyses
- Collaborate with Statistical Programming on tables, figures, and listings for decision-making and regulatory reporting
- Analyze and interpret clinical-trial and non-trial data for program-level decision-making
- Prepare presentations and written reports for project teams, management, and regulatory agencies
- Co-present findings to management
- Conduct research on innovative statistical methods and applications in clinical trial development
Requirements
What you’ll need- PhD or equivalent degree in statistics/biostatistics or related disciplines with internship experience, or MS degree in statistics/biostatistics with more than 5 years’ experience in the pharmaceutical industry as a statistician
- Excellent influence and leadership skills
- Ability to collaborate in a cross-functional environment
- Ability to work productively in a fast-paced collaborative environment
- Demonstrated critical thinking, time management, and effective communication skills
- Solid knowledge of statistical analysis methodologies, experimental and clinical trial design
- Expertise in statistical software such as R or SAS is required
- Ability to travel up to 25% may be required
Benefits
Comp & perks- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical, dental, vision, life, and disability insurance benefits
- Paid time off
- Family support benefits
- Reasonable accommodation during the recruitment process where required