Location: Home or Office Based Anywhere in North America
Closing Date: 29 Dec 16
Type: Full Time
Salary (£): Negotiable
We have an opening for an Associate Director, Statistics in a full-time, salaried capacity. This role can be office based in King of Prussia, PA or home-based in North America.
We have an opening for an Associate Director, Statistics in a full-time, salaried capacity. This role can be office based in King of Prussia, PA or home-based in North America. This role is a Statistician who manages the clinical study and provides planning on multiple clinical studies from multiple clients along with the following duties as listed below.
• Assist in the administration of the department processes, resource and project scheduling; assist in the interviewing and hiring of personnel; and overall training and mentoring of the department staff.
• Responsible for reviewing and approving the overall work of other members in the department to ensure quality; reviewing protocol and CRF; preparing, reviewing and approving statistical sections of the protocol and complex sample size calculations.
• Preparing, reviewing and approving interim, SAP, ISS and ISE; reviewing patient evaluability listings; reviewing and approving data displays and annotation of shell data displays and also complex interim and statistical analysis in support of clinical research; performing complex statistical simulation and developing new statistical methodology.
• Preparing, reviewing and approving statistical report and statistical section or the CSR and also charter for DSMB/DMC. Provide statistical execution and representation of DSMC/DMC and represent as a statistical voting member on DSMC/DMC.
• Acting as Statistical Lead for regulatory submission; attending FDA meetings on behalf of the sponsor along with other leadership duties; prepare and defend bid; miscellaneous tasks as assigned.
• MS or Ph.D. in Statistics/Biostatistics or equivalent with at least 12 years’ experience as a Statistician (MS) or 8 years’ experience as a Statistician (Ph.D.) with clinical trial experience and previous experience with a large portion of the statistical content of at least 2 NDAs and at least 6 years of experience managing people/projects.
• Proficiency in statistical procedures including non-parametric analysis, linear and non-linear models, categorical data and survival analysis techniques.
• Proficiency in SAS and SAS Macro language.
• Must have extended knowledge of the procedures of clinical programming and understanding of data management flow in clinical programming.
• Effective written and oral communication skills along with strong organizational, interpersonal and project management skills.
For more information:
At Chiltern, you'll join a team of like-minded individuals headed by some of the most dynamic and influential leaders in drug and medical device development today. You'll work on cutting-edge global research projects in a fast-paced but collegial atmosphere where you'll have the opportunity to make meaningful - and acknowledged - contributions. You'll have opportunities to grow personally and professionally and abundant room for advancement along with generous incentive programs.
Chiltern is the leading, global mid-sized contract research organization that listens to client needs to deliver customized clinical development solutions. Chiltern’s team of more than 3,700 works across 47 countries to provide flexible, specialized services, with core competencies in Biopharma, Medical Device and Diagnostics, Oncology, Clinical Analytics and Source. Visit Chiltern.com to learn more about responsive solutions that are Designed Around You®.
Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.
1016 W 9th Ave, King of Prussia, United States
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