What are the responsibilities and job description for the Director Biostatistics position at Workila?
The sheer scale of our capabilities and client engagements and the way we collaborate, operate and deliver value provides an unparalleled opportunity to grow and advance. Choose Workila, and make delivering innovative work part of your extraordinary career.Job Description Will manage a small team of 6 members.Provide leadership and guidance as the statistical expert on a project team or within a therapeutic area. For one or more projects, be accountable for all statistical aspects of clinical studies and submissions, including quality, relevance to regulatory perspective, and scientific validity. Act as key statistical consultant within the company. Responsible for project staffing, resource planning and allocation within therapeutic area(s). Responsible for facilitating career development of direct reports and assisting the Department Head with creation and implementation of policies. May have regional or global management responsibility.In some cases, the incumbent could serve as department leader in a specific technical area.Major Duties and ResponsibilitiesOversee statistical support to multiple project teams. Collaborate with clinical and regulatory leads in defining general strategic approach, creating clinical development plans (CDP), and producing individual protocols.Oversee execution of statistical analyses, preparation of the statistical methods and results sections for clinical study reports (CSR), and production of overall summaries.Provide general guidance on definition and documentation of key derived variables needed to support production of tables, listings, and graphs (TLG).Plan and track project activities, timelines, and resource use across projects.Ensure mentoring and development of staff. Encourage personal development in the context of project work.Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOP.Serve as departmental representative on division or corporate-wide teams.MUST HAVE – NO EXCEPTIONSPH.D. (MS) in statistics or related discipline with 10 (12 ) years of pharmaceutical experience, including significant interactions with regulatory bodies, history of successful management (4 years), and expertise in one or more therapeutic areas (ANY).In-depth understanding of the regulatory drug submission / approval process regionally and globally.Experience managing direct reports, assembling teams, and implementing working relationships with external agencies, such as CRO, consultant groups, and research committees.Leadership role in societies or committees relevant to drug development or statistics.Selling PointCan work from home 2 days a week.Additional Information Apply online by clicking on the green label "I am Interested" or call if you have any questions; however, applying online is the best way to apply.#J-18808-Ljbffr
