Principal Biostatistician

Provides independent program level statistical expertise and leadership in clinical development of a compound in early phase or less complex programs, including strategic statistical input to development plans, cross-study analyses, and regulatory interactions.  Independently designs, analyzes, and interprets clinical studies and maintains their statistical and analytical integrity.  Independently represents statistics in writing of protocols and statistical analysis plans, preparing data deliverables for clinical study reports, and interpreting statistical results.  Responsible for all statistical activities and deliverables for the program, leveraging internal and external resources through cross-functional interactions to ensure quality and timely deliverables. 

Responsibilities:

• Independently represent statistics at the program level, providing expertise and leadership to support clinical development
• Propose, evaluate, and implement, as appropriate, innovative, and efficient study designs and methodologies with minimal supervision
• Provide strategic statistical input on the program level in collaboration with the cross-functional team in the development and review of study synopses and protocols, CRFs, data transfer specifications, charters (e.g., DMC, IRC, endpoint adjudication committee), data review/monitoring plans, and clinical study reports, ensuring statistical accuracy and validity, as well as consistency across the program where appropriate
• Provide strategic statistical consultation on the program level to the development of regulatory documents and support regulatory submissions and responses to regulatory questions
• Negotiate statistical timelines with constraints at the program level
• Understand and examine functional issues from a broader strategic organizational perspective. Is a point of influence in setting strategy for the program
• Coordinate with data management, programming, and clinical research to target high quality and consistent data collection at the program level
• Develop statistical analysis plans and corresponding shells and programming specifications to ensure production of quality tables, listings, and graphs (TLGs), implementing and proposing standards as appropriate
• Review and oversee production of TLGs in collaboration with other statisticians and programmers to produce quality, timely deliverables, including any relevant ad-hoc and exploratory analyses
• Responsible for all program level statistical activities and deliverables, including oversight of programming support and any outsourced responsibilities
• Identify program level vendor requirements and participate in the evaluation/selection of analytical vendors. Provide program level oversight, review, and approval of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical deliverables
• Interact with external statistical experts for issues related to study design, methodology and results with minimal supervision
• Anticipate and communicate program level issues that may impact deliverables or timelines; propose and implement solutions where appropriate. Escalate issues to management as needed in a timely manner
• Lead implementation of department standards and process improvements
• Stay up-to-date and contribute to industry advances in statistical methodologies to optimize study designs and analysis methods, and implement innovative approaches as appropriate

Requirements: 

Ph.D. in Biostatistics or closely related discipline with at least 3 years of relevant experience or an MS in Biostatistics or equivalent with at least 6 years of relevant experience. Excellent analytical and problem-solving skills with a keen understanding of statistical principles and concepts, and ability to defend results and analyses.  Experience with advanced clinical study designs and analysis methods, descriptive and inferential statistics, and regulatory interactions. Advanced knowledge of the pharmaceutical industry, including understanding of the clinical drug development process.  Extensive knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical studies and regulatory submissions.  Strong statistical programming skills.  Ability to work both independently and collaboratively within a cross-functional team.  Strong oral and written communication skills, as well as interpersonal and organizational skills.  Ability to manage internal and external technical and business relationships (e.g., with CROs)