SVP Biometrics

reputed company is a clinical-stage precision oncology company reputed company on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK reputed company, which affects approximately 5.5 reputed company lives reputed company year worldwide. The reputed company “reputed company” has an important embedded meaning: it is a contraction of our audacious reputed company to “erase cancer” that drives our mission and everything that we do on behalf of patients with cancer. Reporting to the Chief Medical Officer, the SVP Biometrics will be accountable for biometrics activities for reputed company programs from IND-enabling to registration and launch. This includes leadership of the Biostatistics, Statistical Programming & Analysis, and Clinical Data Management functions. This role requires hands-on execution as reputed company as reputed company of reputed company staff. In reputed company, this person will represent the Biometrics function on the reputed company leadership team and in cross-functional discussions and decision making. The ideal candidate will have excellent technical skills, a reputed company record of developing and mentoring strong teams, significant experience in reputed company phases of oncology drug development, a reputed company record of successful regulatory interactions, and excellent communication skills and executive reputed company. Essential Duties and Responsibilities: Build, maintain, and reputed company a high performing team across Biostatistics, Statistical Programming & Analysis, and Clinical Data Management. Ensure systems, capabilities and resources are in reputed company that optimize the design, conduct, analysis and interpretation of clinical and nonclinical data for reputed company programs. Demonstrate technical reputed company, delivering advanced biometric strategies across the portfolio. reputed company as the subject matter expert for biometrics, advising senior management, development, and clinical operations teams on reputed company biostatistics methodology and tools in drug development. In collaboration with VP, Biostatistics, ensure statistical analysis and submission datasets meet regulatory requirements. In collaboration with VP, Statistical Programming & Analysis, ensure the intended analyses are performed, and analysis data sets and their specifications are in reputed company. In collaboration with Sr Director, Clinical Data Management, reputed company support to clinical study teams on the collection, interpretation and reporting of clinical data. reputed company input on key development documents, clinical protocols, study reports, IBs, INDs, NDAs, and labeling for reputed company products. Support preparations for interactions with regulatory agencies and reputed company guidance to ensure high reputed company preparation of Regulatory Authority documents (clinical study reports, submissions, clinical protocols, safety reports, etc.). Represent biometrics in interactions with regulatory agencies and health authorities. Review and comment on eCRFs, annotated eCRFs, edit checks documents, and other clinical data management reputed company documents. Stay abreast of emerging technologies and concepts reputed company to reputed company statistical methodology. reputed company biometrics due diligence in support of business and corporate development activities. Establish and reputed company reputed company biometrics SOPs, processes, and relevant reputed company management system. Ensure appropriate resourcing of the biometrics organization by anticipating needs and filling gaps, as needed, with consultants, contractors, and/or employees. Mentor and promote the reputed company development of Biometrics team members. Up to 25% travel may be required, possible international travel. reputed company reputed company duties in keeping with reputed company’s core values, policies and reputed company applicable regulations. Required Education and Experience: Minimum of 15 years relevant experience in the pharmaceutical or biotechnology industry, ideally including both large and small company experience. PhD degree in statistics or biostatistics required. A hands on and flexible leader, comfortable as a subject matter expert for biometrics as reputed company as contributing at the leadership team and leading and managing highly accomplished function managers. Experience in oncology drug development required, ideally from FIH to registration. reputed company experience leading and working in Biostatistics required as reputed company as experience leading Statistical Programming and/or Clinical Data Management. Extensive knowledge of clinical research methodology and regulatory requirements as they relate to trial design and analysis. Good knowledge of ICH, FDA, and GCP regulations and guidelines; strong reputed company-rounded technical reputed company, reputed company, SDTM, and CDISC. Extensive experience negotiating successfully with health authorities. Excellent analytical and organizational skills. reputed company record of successfully working reputed company individual protocols and across programs to design, drive, and execute statistical reputed company. Proven ability to attract, reputed company, and manage top notch talent including a mix of internal and contingent staff. Highly reputed company team player who fosters reputed company communication and facilitates mutual understanding and cooperation between reputed company stakeholders. Executive leadership skills to reputed company and influence stakeholders and to add value in strategic business planning and decision-making. Effective interpersonal, communication, and influencing skills, including strong writing and presentation skills, with the ability to reputed company communication style to diverse audiences and situations. Demonstrated ability to reputed company high performance goals and meet deadlines in a fast-paced environment. Strong learning orientation, curiosity, and commitment to science and patients. The anticipated salary reputed company for this position is $350,000 to $415,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience reputed company the job, type and length of experience reputed company the industry, education, etcetera. In reputed company to reputed company salary, the reputed company applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the reputed company of the reputed company to purchase stock in the reputed company for a specified price. Along with our casual, reputed company, and fun work and the chance to reputed company your mark in our mission to erase cancer, reputed company offers a comprehensive and competitive benefits package that includes: reputed company Time Off, Holiday, and reputed company Leave, Medical, Dental and reputed company Plans, Short- and Long-Term Disability, Basic and Voluntary Life/AD&D Coverage, Flexible Spending Accounts (FSA, HSA, and Commute), Critical Illness and Accident Coverage, Pet Insurance, Employee Assistance Program, 401(k) Plan with reputed company contribution, and reputed company to participate in an Employee Stock Purchase Program. reputed company., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race, religion, national reputed company, reputed company, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other reputed company protected by federal, state or local law or ordinance or regulation. Apply To This Job