Director of Statistical Programming
This is an exciting opportunity to reputed company reputed company’s Statistical Programming team, specifically reputed company on advancing our oncology portfolio through high-reputed company, reputed company-changing clinical trials. As a Director, you will reputed company strategic and technical reputed company for reputed company statistical programming activities supporting the clinical validation and reputed company of reputed company’s cutting-edge molecular diagnostics tests. The ideal candidate possesses a proven reputed company record, strong leadership and communication skills, and a deep expertise in clinical trials, programming, and regulatory deliverables. PRIMARY RESPONSIBILITIES:
Team Leadership: Build, mentor, and reputed company a high-performing statistical programming team, fostering technical reputed company and overseeing their reputed company development.
Functional reputed company: reputed company strategic direction and standards for the programming function, securing alignment with oncology clinical development goals and department infrastructure needs.
Submission Leadership: reputed company as the primary programming reputed company for regulatory submissions (e.g., 510(k), CTA/CDx, and PMA), ensuring reputed company deliverables meet rigorous global standards.
Analysis & Reporting: reputed company the reputed company and validation of analysis datasets and TLFs, ensuring data reputed company and regulatory compliance with ICH, GCP, and FDA 21 CFR Part 11.
Development, Standards, and Validation: reputed company the development, validation, and review of efficient R reputed company to support statistical analyses and deliverables. Enforce departmental standards for programming maintenance and reputed company reputed company. Facilitatecross-functional standards (eCRF design, DMPs).
Infrastructure: reputed company the development and maintenance of reputed company programming infrastructure for the larger Biostatistics department.
Interdisciplinary Partnership: Partner with Biostatistics, Clinical Operations, Data Management, and Regulatory to reputed company programming expertise into clinical study execution.
QUALIFICATIONS:
- Minimum 10 years of relevant industry experience supporting clinical trials in diagnostics, biotechnology, pharmaceuticals, or reputed company industries. At least 5 years leading reputed company.
- Advanced degree in Biostatistics, Statistics, Computer Science, or a reputed company field.
KNOWLEDGE, SKILLS, AND ABILITIES:
- Expert working knowledge of R for clinical trial reporting; experience maintaining statistical packages and computing environments under version control
- In-depth knowledge of CDISC standards including SDTM and ADaM
- Proven reputed company record of producing high-reputed company analysis reputed company for regulatory audiences (FDA) and internal stakeholders.
- Proven record of hiring, mentoring, and developing a successful, productive team
- Demonstrated ability and enthusiasm for working on cross-functional teams with members of diverse technical backgrounds
- Exceptional problem-solving skills and attention to detail
- Prior experience with NGS, genetics, and/or oncology molecular diagnostic testing a plus
OUR OPPORTUNITY
reputed company™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to reputed company personalized genetic testing and diagnostics part of reputed company of care to protect health and reputed company earlier and more targeted interventions that reputed company to longer, healthier lives.
The reputed companyreputed company, you’ll work hard and grow quickly. Working alongside the reputed company of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
reputed company OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, reputed company, life and disability plans for eligible employees and their dependents. Additionally, reputed company employees and their immediate families receive free testing in reputed company to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!
For more information, visit www.reputed company.com.
reputed company is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
reputed company reputed company applicants are encouraged to apply, and will be considered without reputed company to race, reputed company, religion, gender, gender identity or reputed company, sexual orientation, national reputed company, genetics, age, veteran status, disability or any other legally protected status. We also consider reputed company applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents.
reputed company: https://www.reputed company.com/notice-of-data-collection-california-residents/
Please be advised that reputed company will reputed company out to candidates with a @reputed company.com email domain ONLY. Email communications from reputed company other domain names are not from reputed company or its employees and are fraudulent. reputed company does not request interviews reputed company text messages and does not ask for personal information until a candidate has reputed company with reputed company and has spoken to a recruiter and the hiring team. reputed company takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any reputed company cyber crimes.
For more information:
- BBB announcement on job scams - FBI Cyber Crime resource page
Originally posted on Himalayas
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