Associate Director Statistics

Associate Director Statistics

PRIMARY FUNCTION / PRIMARY GOALS / OBJECTIVES:
Provides statistical support through own efforts and those of their staff for clinical development strategy; for the design, analysis and reporting of clinical trials; and for interacting with regulatory agencies regarding the results of these activities.

MAJOR RESPONSIBILITIES:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Protocols: Ensures clinical study protocols are statistically sound and have high quality.

Database Activities: Ensures that clinical study databases are designed and created such that short and long term project needs can be achieved.

Statistical Analyses: Demonstrates extensive understanding of statistical concepts and methodologies, and ensures that these are properly implemented and documented in protocols, SAPs and reports. Recognizes and corrects/communicates flaws and limitations in scientific reasoning and statistical interpretation. Ensures that advanced techniques are applied when necessary to solve problems. Represents GPRD Statistics in the strategic planning process for the therapeutic area(s) for which they are responsible.

Scientific Reports and Publications: Provides strategic guidance for the content of reports and publications. Effectively presents scientific arguments in reports. Provides in-depth critical review for scientific reports and publications. Ensures accuracy, scientific rigor and appropriateness of statistical components for reports, publications and other documents for public dissemination or internal decisions.

Consultation: Works collaboratively with multiple stakeholders to develop scientifically appropriate development strategies per agreed timelines. Represents statistics, programming and data management in assigned Global Project Teams (GPTs) to provide function input to compound development. Serves as a “liaison” between GPT and statistics/DM functional area to ensure timely communication of GPT updates, proper statistical strategies and alignment of priorities between GPT and functional management. Demonstrates understanding of drug development principles for assigned projects. Effectively and persuasively presents statistical concepts, evidence, interpretations and logical arguments to management, regulatory agencies and scientists. May represent GPRD Statistics on data monitoring committees.

Training, Supervising and Mentoring: Effectively mentors other development stakeholders with regards to statistical methodology and departmental operations. Provides appropriate background, training and motivation to staff. Manages statisticians by appropriately delegating assignments, reviewing activities and defining and ensuring review of deliverables so that projects are delivered on time with suitable quality. Arranges appropriate training opportunities for staff to facilitate their timely career development. Ensures that self and staff are compliant with training requirements.

Project Coordination and Regulatory Activities: Works with Director, Statistics to ensure that the clinical development program incorporates sufficient statistical and scientific rigor and quality to meet stated objectives and global regulatory requirements. Demonstrates an accurate understanding of current regulatory requirements and issues that could affect the design, conduct, analysis or interpretation of clinical programs. Ensures that all applicable regulatory requirements for work processes are met. Participates in discussions with FDA and other regulatory agencies as needed. Works with Director to build relationships between GPRD Statistics and outside investigators and medical/scientific experts.

ACCOUNTABILITY / SCOPE:
With Director Statistics, accountable for providing proposals and assessments of statistical strategies; collaborating with representatives from various scientific and operational functions to ensure success of project teams. Also responsible for management and development of assigned staff.

Project lead experience required. Management experience not required. High degree of technical competence and communication ability, both oral and written. Highly competent in experimental design, descriptive and inferential statistics, and computer systems. Pharmaceutical or related industry experience with clinical trials, including interaction with regulatory agencies, especially FDA.

Jointly with other project team members, develops and evaluates options for meeting team goals under time and budgetary constraints. Proposes and evaluates options for responding to questions from internal and external sources, including regulatory agencies. Implements the agreed upon solution after discussions with other stakeholders.