Senior Clinical Trials Programmer Lead
14 ore fa
About the Role
">We are seeking a highly experienced and motivated Clinical Trials Programmer Lead to join our dynamic team. In this role, you will be responsible for overseeing the statistical and programming aspects of multiple projects, acting as the lead programmer, project lead, or project oversight lead for a client/asset.
">Your Key Responsibilities
">- ">
- Serve as a lead programmer or project lead on selected studies or drug programs of all complexity and size scale.">
- Work directly with teams and clients to conduct team meetings, develop and maintain project timelines, assess and forecast resources needed, and ensure study budgets and familiarity with any relevant contractual obligations or limits with our clients.">
- May serve in a senior project oversight role on selected projects.">
- May serve in a contributor or reviewer role of key submission materials for regulatory authorities.">
- Provide general infrastructure support to the department, representing the company at industry conferences, presenting/teaching at department meetings, establishing training materials for the department, contributing to documents or policies, and contributing to process improvement and department initiatives.">
- Increase knowledge base and professional skills for self and junior team members, in areas including programming technology and techniques, clinical trials, and developments in the pharmaceutical industry.">
- Work to increase the visibility of the company by encouraging the publication of articles in industry journals and presentations at conferences.">
- Manage staff of small team, including interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical coaching and mentoring, employee counseling, and separations.">
Requirements
">To succeed in this role, you will need:
">- ">
- A strong background in computer science, statistics, biostatistics, mathematics or related field.">
- At least 3 years of experience that provides the knowledge, skills, and abilities to perform the job requirements.">
- Preferred is at least 6 years of clinical trial experience as a statistical programmer and at least 1 year of leadership experience.">
- Expert level knowledge and highly resourceful hands-on experiences in SDTMS/ADaMs /TLFs specifications and programming.">
- Strong SAS programming skills and understanding of database structures.">
- Excellent written and verbal communication skills, including proficiency in the English language.">
- Capable of working in a multi-disciplinary team setting and adapting to changing priorities.">
- Basic understanding of statistical principles applied to the design and analysis of clinical trials.">
- Ability to supervise and mentor as shown by leadership of projects and team members.">
- Capable of managing project budgets and risks, with a strong attention to detail.">
- Familiarity with ICH Statistical and reporting guidelines and GCP.">
What We Offer
">We offer:
">- ">
- A competitive salary range of $120,000 - $180,000 per annum.">
- An annual incentive plan bonus.">
- Healthcare benefits.">
- A range of employee benefits.">
- Opportunities for career growth and development.">
- A collaborative and dynamic work environment.">
- The chance to work on exciting and challenging projects.">
- Professional training and development opportunities.">
- A comprehensive benefits package.">
About Us
">We are Thermo Fisher Scientific, a global leader in the life sciences industry. Our mission is to enable our customers to make the world healthier, cleaner and safer. We offer a supportive and inclusive work environment, where diversity and inclusion are valued.
">How to Apply
">If you are a motivated and experienced professional looking for a new challenge, please submit your application. We look forward to hearing from you
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