The purpose of this position is to provide compound level / development phase statistical expertise and leadership by:
- Providing statistical leadership in the design, analysis, and interpretation of clinical studies at a compound level with complex programs
- Promoting innovative design and efficient analysis methodology.
- Providing strategic statistical input for feasibility assessments, development plans, cross-study analyses and regulatory submissions.
- Improving and using standards to maximize global data integratability, interpretability and compound level efficiency
- Leveraging internal and external resources to achieve quality, timely and cost-effective compound level and submission deliverables.
- Independently representing Statistics function in interactions with regulatory authorities on study design and submissions.
- Actively participate in and contribute to decision making related to clinical development strategies, regulatory strategies, and commercial strategies.
- Promote innovative design and analysis methodology
- Provide statistical leadership in design, analysis, and interpretation of clinical studies at a compound level with large complex programs.
- Independently represent statistics function on global teams in support of clinical studies and compound level programs.
- Provide strategic statistical input to feasibility assessments, development and submission plans, and defense of regulatory submissions. Negotiate timelines (statistical) at compound level.
- Plays a leadership role in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables.
- Oversee definition and implementation of compound-level database (including derived database), analysis and reporting standards. Improve or use existing standards to ensure maximization of global integratibility and interpretability of data and enhance efficiency at compound level. Coordinate with Data Management, Programming, Clinical and PV to target high quality databases and specifications at compound level.
- Plan and direct compound level analysis and reporting activities (eg, tables, listings, graphs) including work of other statisticians and programmers.
- Identify compound level vendor requirements and participate in the evaluation/selection of vendors. Provide compound level analytical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical vendor deliverables.
- Identify and interact with external statistical experts for issues related to study design, methodology and results.
- Anticipate and communicate internal and external resource and quality issues that may impact deliverables or timelines of the compound level program. Propose and implement solutions. Escalate issues to management as appropriate in a timely manner.
- Lead the implementation of department standards and process improvements.
- Lead evaluation and implementation of alternative analysis methodology and data presentation techniques.
- Monitor and contribute to industry advances in statistical methods to optimize study designs and statistical analysis methods, and implement innovative approaches at a compound level.
EDUCATION, EXPERIENCE AND SKILLS:
- Generally requires PhD in statistics or biostatistics with at least 7 years of relevant pharmaceutical industry experience or MS in statistics or biostatistics with at least 10 years of relevant pharmaceutical industry experience. For statisticians with exceptional talent who have demonstrated core capabilities of a Sr. Principal Statistician, 6 years of pharmaceutical industry experiences with a PHD may be considered.
- Experience with global regulatory submissions.
- Advanced knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics.
- Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents.
- Extensive knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions.
- Good knowledge of statistical programming languages (including SAS), software, techniques, and processes. Excellent oral and written communications skills.
- Strong project management skills.
- Strong collaborative skills and ability to work with a cross-functional team.