Senior Manager/ AD of Biostatistics
Objective of Position
We have an exciting opportunity for a Senior Manager or Associate Director of Biostatistics, depending on qualifications and experience, based in South San Francisco, CA. This position is to serve as a lead statistician for oncology and hematology studies, and to coordinate activities with other functional groups to ensure timeliness and quality of study deliverables for biostatistics.
Essential Duties/ Responsibilities
- Provide statistical expertise for design, analysis and reporting of clinical or scientific research studies
- Collaborate with Clinical Sciences, regulatory affairs and other functions on protocol development, including choosing an appropriate study design and statistical methodology, defining endpoints, calculating sample size, and writing statistical sections of the protocol.
- Develop statistical analysis plans and analysis specifications.
- Collaborate with statistical programming to ensure that appropriate programs and
documentations are being developed for datasets development and outputs generation, and ensure the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately.
- Collaborate with data management and clinical operations over the course of trials to provide statistical input to study conducts and database development as well as data collection/cleaning.
- Collaborate with clinical pharmacology and translational medicine group to provide statistical input and support as needed Collaborate in publications, assist in data interpretation, and ensure consistency and accuracy in data presentation
- Interact with medical writing and other functions on regulatory documents containing
statistical information and clinical data (e.g. Clinical Study Reports, Summary
documents for NDA submissions)
- Contribute to the development of functional-level standards, SOPs, and templates.
- Represent biostatistics on study/project teams.
- Establish and maintain effective working relationships with study/project teams.
- Oncology drug development experience is preferred, though not required.
- Experience with early development studies is desirable.
- Competent in design, descriptive and inferential statistics in clinical trials, biopharmaceutical applications.
- Ability to work within a team and work independently are required.
- Excellent verbal and written communication skills are required.
- Good interpersonal and project management skills are essential.
- Knowledge of SAS and/or R is strongly desirable.
Ph.D. or M.S. in statistics, biostatistics, or related field with minimum 5 (Ph.D.) – 10 (M.S.) years of experience as biostatistician in the biotech/pharmaceutical industry or medical research.
With Kelly, you'll have access to some of the world's highest regarded scientific organizations—providing you with opportunities to work on today's most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you'll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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