Biostatistics Director, Biostatistics South San Francisco, California

Orbis Clinical is seeking a remote-based Director, Biostatistics for 12 monthy.

The Director, Biostatistics will be a leader of biostatistics and will oversee and provide statistical support to the development of client’s therapeutics in close collaboration with Clinical Development, Regulatory Affairs, Drug Safety, Clinical Pharmacology, Data Management, Translational Development and Program Management team members. Will be a key contributor to Clinical Development Plans, including the creation and execution of clinical protocols and statistical analysis plans (SAPs) as well as regulatory submissions and publications. Will oversee, manage, and guide the biostatistics team (both internally and externally) to ensure high quality and timely deliverables. Will serve as the statistical representative in the defense of the company position and approach on statistical issues globally. This role has significant stakeholder management responsibility with business partners. The biostatistician leader has responsibility for driving optimal study designs, data collection, analytic approaches, and rigorous interpretation of data. This person will interact with external vendors, key opinion leaders and regulatory agencies.

Job Description

• Lead the Biometrics members in cross-functional teams.
• As a key member, provide strategic input to clinical teams, oversee development of clinical development plans and protocols in coordination with clinical operations, clinical sciences, clinical pharmacology, regulatory, and commercial functions.
• Set statistical standards and methods to ensure quality delivery of clinical, translational medicine, and pharmacology datasets, all in coordination with each specific function and data management.
• Oversee, author (as needed), review, and approve protocols, SAPs, CRFs, CSRs, associated publications, and other study level documents.
• Manage and/or oversee the biostatistical teams on the responsible drug development programs, including all biostatistics personnel (line function members, programmers, consultants, and vendors) to produce statistical software and generate high quality TFLs.
• Act as a resource and mentor to the development teams of the responsible clinical programs. Translate scientific questions into statistical terms and statistical concepts into layman terms to support the team needs. Challenge group assumptions and enforce rigorous statistical methodologies.
• Assess, provide direction, and resolve complex stakeholder concerns and represent the biostatistics function internally and externally.
• Stay current with applied statistical methodology and regulatory standards.
• All contractors are expected to act with integrity and in full compliance with applicable laws, regulations, and company policies, including company’s Code of Conduct.
• Contractors must demonstrate good judgement and ethical behavior in all business activities, maintain patient and product safety as a top priority, and report any suspected violations of law or Company policy through appropriate channels

Requirements:

• Ph.D. or M.S. in Statistics or closely related field.
• Have 12+ years statistical experience in drug development, including at least 8 years in oncology drug development in pharmaceutical industry R&D.
• Extensive hands-on experience from writing complex protocols and SAPs to performing interim and CSR analyses in oncology clinical development from Phase 1 study to regulatory submission.
• Direct involvement and responsibility and hands-on experience in NDA/BLA submissions with track records of approval of oncology drugs.
• Sound knowledge of clinical trial design concepts and statistical methodologies with in-depth understanding in time-to-event analysis methodologies.
• Demonstrated strong ability and leadership to work in a cross-functional team environment with good interpersonal, communication, writing and organizational skills.

Compensation Details:

• Orbis Clinical provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location. 
• The Pay Range for this position is $120-$130 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k).

EEO and Reasonable Accommodation Statement:

Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.