Penfield Search Partners
Contact: Barbara Day – 201.784.9028 – bday@penfieldsearch.com
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future with our Client. Join us as a Principal/Sr. Principal Statistician in their Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Principal/Sr. Principal Statistician, you will be empowered to provide statistical leadership and work in complex programs, and a typical day will include:
Objective: The purpose of this position is to provide indication level / development phase statistical expertise and leadership by:
- Providing statistical leadership in the design, analysis, and interpretation of clinical studies at an indication 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 integrability, interpretability and indication level efficiency
- Leveraging internal and external resources to achieve quality, timely and cost-effective indication level and submission deliverables.
- As appropriate independently representing Statistics function in interactions with regulatory authorities on study design and submissions.
Accountabilities:
- 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 an indication level within large complex programs.
- As appropriate 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 indication level.
- Plays a 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 indication-level database (including derived database), analysis and reporting standards.
- Improve or use existing standards to ensure maximization of global integrability and interpretability of data and enhance efficiency at indication level.
- Coordinate with Data Management, Programming, Clinical and PV to target high quality databases and specifications at indication level.
- Plan and direct indication level analysis and reporting activities (e.g., tables, listings, graphs) including work of other statisticians and programmers.
- Identify compound level vendor requirements and participate in the evaluation/selection of vendors.
- Provide indication 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 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.
Education, Experience and Skills:
- Generally requires PhD in statistics or biostatistics with at least 4 years of relevant pharmaceutical industry experience or MS in statistics or biostatistics with at least 6 years of relevant pharmaceutical industry experience.
- PhD required for Oncology roles.
- 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.