Associate Director, Biostatistics

Overview:

Primary purpose and function of this position: This candidate will provide leadership and guidance as the statistical expert to project teams for all TEVA Medical Affairs’ research projects.  He or she will be accountable for all statistical aspects of clinical studies and submissions, including quality, relevance to regulatory perspective, scientific validity and will evaluate data for submissions and responses to regulatory agencies. This pivotal role will oversee and provide statistical support to multiple teams, as well as collaborate with Scientific, Clinical, Operational and Regulatory leads in defining general strategy, providing input into Medical Operating Plans (MOPs) and/or Clinical Development Plans (CDPs), and study protocols.  This individual will work independently, or with other statistical departmental members or external consultants, to develop effective statistical approaches applicable to projects for multiple products across therapeutic areas. Candidate will act as a key statistical consultant within the TEVA North America Brand organization on statistical allocations and resources within the projects, and will assist to direct management with creation and implementation of relevant policies.

Responsibilities:

Major duties and responsibilities that are critical and necessary, and that must be done to achieve this position’s overall objective: Produce statistically valid support to studies within MOPs and/or CDPs involving one or more studies designed to lead to a key decision point or submission, related protocols, and statistical analysis plans (SAPs) consistent with overall project objectives Provide study design input and consultation for clinical research protocols and drug development plans Provide consultation on clinical endpoint assessments and sample size planning for clinical studies Prepare statistical sections of clinical protocols in collaboration with clinical research. Provide statistical interpretations and explain statistical methodology; as well as provide practical explanations to non-statisticians[ Works with Data Management and Clinical Research personnel to provide statistical input for CRF design Oversee execution of statistical analyses, preparation of the statistical methods interpretations of results sections for clinical study reports (CSRs), and production of overall summaries Serve as departmental representative on Medical Affairs or corporate-wide teams, as determined by its management.  Advocate application of statistical thinking in decision-making.   Work effectively with leaders in other functional areas Assist in mentoring and development of project staff on relevant project aspects.  Interact and interface with customers, medical writers and others when communicating the statistical information, identify and maintain positive relationships with key external contractors, consultants and clients, key project or area leaders from other functional areas within company, opinion leaders, and regulators. Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOPs.  Within area of responsibility, updates procedures or practices as needed to remain in compliance.  Assures that utilized procedures and practices meet industry standards and are consistent with the internal SOPs

Qualifications:

Qualifications necessary to perform successfully in this position: Education required:  PhD in statistics, or Applied Statistics, or related quantitative area related discipline with 5 years of experience Years of experience required:  7 to 12 years Specific type of experience required: Effective oral and written communication skills to communicate statistical concepts and analysis to non-statisticians.  Proficiency in SAS and JMP software, including the ability to write complex SAS macros. Specific type of experience preferred:  Pharmaceutical industry experience, including significant interactions with regulatory bodies, and expertise in one or more therapeutic areas.  Familiar with DOE, QbD, SPC, simulation and design of sampling plans; Oracle database, and GMP and ICH guidelines