Randstad Clinical Operations in Deerfield, Illinois
salary:$76 - $89.65 per hour
date posted:Thursday, September 14, 2017
The purpose of this position is to provide statistical expertise and leadership in US medical affair by:
Independently designing, analyzing and interpreting clinical studies , HEOR and real world data at a product level.
Providing strategic statistical input for feasibility assessments, cross-study analyses and marketing activities.
Leveraging internal and external resources to achieve quality, timely and cost-effective product level deliverables.
Independently representing Statistics in interactions with clinicians and other functions.
Independently represent statistics function on clinical teams in support of clinical studies and product level programs.
Provide strategic statistical input to feasibility assessments, development and marketing plans. Negotiate timelines (statistical) at product level.
Plays a leadership role in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report, and other analysis documents, ensuring accurate and statistically valid deliverables.
Oversee definition and implementation of product-level database (including derived database), analysis and reporting standards. Plan and direct product level analysis and reporting activities (eg, tables, listings, graphs) including work of global statisticians and programmers.
Identify product level vendor requirements and participate in the evaluation/selection of vendors. Provide product level analytical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical vendor deliverables.
Identify and interact with external statistical experts for issues related to study design, methodology and results.
Anticipate and communicate internal and external resource and quality issues that may impact deliverables or timelines of the product level program. Propose and implement solutions. Escalate issues to management as appropriate in a timely manner.
Monitor and contribute to industry advances in statistical methods to optimize study designs and statistical analysis methods, and implement innovative approaches at a product level.
Education & Qualifications
Generally requires PhD in statistics or biostatistics with at least 5 years of relevant experience or MS in statistics or biostatistics with at least 7 years of relevant experience. For statisticians with exceptional talent who have demonstrated core capabilities of a Principal Statistician, 3 years of pharmaceutical industry experiences with a PhD in statistics or biostatistics may be considered.
Experience with advanced study design or at least one NDA/CTDs, post marketing analysis or HEOR.
Advanced knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics.
Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents.
Extensive knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions.
Good knowledge of statistical programming languages (including SAS), software, techniques, and processes. Working knowledge of UNIX operating systems, and common software products and technologies used in conjunction with SAS (e.g., Microsoft Office products).
Excellent oral and written communications skills.
Strong project management skills.
Strong collaborative skills and ability to work with a cross-functional team.
Ability to sit and stand for long periods of time.
Carrying, handling and reaching for objects.
Ability to lift and carry over 25 pounds.
Manual dexterity to operate office equipment i.e. computers, phones, etc.
Cultural Environment (How big of a team are they working on/Who are they reporting to): a small team and work with Sr. director of statistics in USMO Day in the Life (What kind of duties will they be primarily focused on a daily basis): working with other team members and perform data analyses
Top 3 Qualities/Skills for someone that will be most successful in this role:
excellent inter-personal skill
good communication skill Interview
Expectations/Schedule: first phone screen, then on-site interview for local candidates, otherwise face-face interview via skype if possible.