Head of Biometrics

POSITION SUMMARY: 

The Head of Biometrics reports to the Chief Medical Officer and is responsible for providing strategic statistical input related to program and portfolio decisions.  The successful candidate will partner with cross functional leaders in the design and conduct of clinical studies for the evaluation, interpretation and preparation of study results.  

This individual will oversee the Biometrics function, ensure systems, capabilities and resources are in place that optimize the design, conduct, analysis and interpretation of clinical and nonclinical data for each program.  In addition, the Executive Director will be accountable for overall management of the function such as planning and oversight of the budget, managing a strong team, and identifying technology needs or other gaps.   

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Lead the biostatistics, programming and clinical data functions with a clear vision and purpose
• Ensure that program development teams obtain sufficient strategic input and technical expertise on statistical methodologies for clinical and clinical pharmacology studies 
• Provide strategic guidance to ensure high quality preparation of Regulatory Authority documents i.e. clinical study reports, submissions, clinical protocols and safety reports
• Ensure the accurate communication of clinical trial data internally and to Health Authorities, the academic community, and healthcare providers; ensure that the interpretation of data obtained from trials conducted internally or by collaboration partners, CROs and competitive data is accurate, scientifically sound and credible
• Identify technology needs or other gaps; identify and communicate risks to the business and develop solution oriented approaches to address or mitigate risk
• Oversee the continued optimization of state-of-the-art, best practice systems for biostatistics, data management and programming while promoting innovation
• Participate in the Development Senior Leadership Team meetings; develop strong and collaborative work relationships with key business stakeholders i.e. Project Team leaders, functional heads within Development, Research and others
• Partners with Medical Affairs and Commercial to provide statistical support for publications (Posters, Manuscripts etc.)
• Mentor and coach direct reports to maximize their potential
• Other projects/ duties as needed

KNOWLEDGE AND SKILL REQUIREMENTS:  

• PhD in statistics or biostatistics required with minimum of 15 years of experience in the pharmaceutical and/or biotechnology industry 
• Management experience with proven capability as a successful leader in a strategic multifunctional environment; highly skilled in leading change 
• Strong business acumen and critical thinking skills
• Must possess a comprehensive and detailed understanding of statistical experimental designs and analyses, clinical trial requirements and statistical technical requirements such as SAS, SDTM and CDISC
• Understanding of regulatory guidelines that affect statistical deliverables including ICH, FDA and GCP regulations
• Experience with the management and statistical analysis of data obtained from Phase I-III clinical trials or studies
• Experience in immunology, hematology and or oncology studies preferred
• Experience with PLA/NDA/MAA submissions a must including ISS, ISE development
• Extensive experience negotiating successfully with health authorities
• Strong interpersonal and effective communication (oral and written) skills
• Ability to efficiently manage multiple CROs
• Rigel requires all employees to be vaccinated against COVID-19 (subject to any legally required exemptions)

WORKING CONDITIONS:  

• PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear.   Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.  
•  WORK ENVIRONMENT:  The noise level in the work environment is usually moderate.  Some travel may be required.  Exposure to chemicals.

Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.