Sr. Manager, Biostatistics

As an organization whose mission is to translate science into global public health impact , working on vaccines and therapeutics, IAVI has a vaccine policy which states that subject to applicable law, we require all U.S. and Puerto Rico based employees to be vaccinated for COVID-19, unless they have an approved medical or religious exemption or accommodation. We are committed to supporting our employees during this process as we work to ensure a safe and healthy work environment. 

Position Description

Job Title: Senior Manager, Biostatistics

Location: US - Remote

Reports to: Senior Director, Biostatistics and Data Management

Position Summary:

IAVI is seeking a Senior Manager, Biostatistics who will oversee Contract Research Organization (CRO) vendors for IAVI biostatistical and programming activities in support of Phase I - Phase IV clinical trials. The successful candidate will be a member of the Clinical Development (CD) department and will be responsible for providing guidance to the CD team regarding trial design, endpoint selection, statistical analysis, and vendor selection for IAVI’s clinical trials. In addition, this position is also responsible for managing timelines relating to key milestones and ensuring outsourced work is performed with high quality.

Key Responsibilities:

• Provide oversight of outsourced biostatistical activities, coordination with other functional areas, and management of overall timelines, resources, and quality.
• Oversee biostatistics and programming-related responsibilities, including protocol development, trial start-up, randomization specifications, case report form (CRF) development, statistical analysis plan (SAP) and table shells development for interim and final analyses, statistical programming, safety reporting, Clinical Data Interchange Standards Consortium (CDISC) compliance, and all associated documentation for electronic trial master file (eTMF) filing.
• Act as a liaison between biostatistics vendors and the CD team, in particular Medical Monitors, Clinical Operations, and Data Management, by providing guidance on biostatistical aspects of clinical trials, such as randomization, CRF design, SAP development, safety reporting, resourcing, timelines, metrics, and other biostatistical support.
• Maintain biostatistics-related eTMF materials for IAVI clinical trials.
• Ensure CDISC/CDASH standards are applied by vendors and maintain a global CRF library appropriate for all IAVI clinical trials.
• Oversee biostatistical workflow of IAVI-contracted CROs to maximize efficiency across all clinical trial biostatistics-related deliverables. 
• Develop and review external (third party) data transfer agreements; consult with CROs to integrate external data into study programming process flow. 
• Review SDTM and ADaM dataset specifications to ensure conformity to CDISC implementation guidelines and standards, as well as SDTM and ADaM datasets prepared by CROs to ensure consistency with dataset specifications.
• Provide/facilitate support as needed (technical, clinical) to ensure efficient action, collaboration and resolution of biostatistical issues.
• Assist QA team in performing vendor audits, as required.
• Write and revise relevant departmental Standard Operating Procedures (SOPs).
• Ensure compliance with departmental SOPs. 

Education and Work Experience:

• MS or MPH degree in Statistics, Biostatistics, or related field is required.
• Minimum 7 years of experience in the pharmaceutical industry (biotech, pharmaceutical company, CRO) in Biostatistics and SAS programming (Base SAS, SAS/STAT, SAS/GRAPH and SAS macro language).

Qualifications and Skills:

• Design and analysis of safety, immunogenicity, and/or efficacy endpoints for early to late-stage vaccine trials are required.
• Vendor oversight of programming and statistical deliverables is required.
• Experience developing SAS macros, database retrieval for data review and statistical programming, CDISC standards for programming of derived datasets, and using the SAS Output Delivery System to output tables, listings and figures is required.
• Experience with various eDC platforms (e.g., Medidata Rave, IBM eClinical), along with tools such as eCOA/ePRO, eDiary, and IWRS as applied to clinical trials is required.
• Proven ability to be innovative, set realistic timelines, and provide leadership as part of a clinical study project team is required.
• Proven ability to implement GCP guidelines is required.
• Flexibility to change priorities and be comfortable with changing deadlines to meet organization needs is required. 
• Attention to detail, with the ability to work on multiple projects with overlapping schedules and priorities is required.
• Ability to work independently, as well as in a team, while exercising discretion, is required.
• Solid knowledge of EMA and ICH regulations, CDISC, and FDA guidance is required.
• Proven track record of reviewing and understanding study protocols, SAPs, and other clinical related materials is required.
• Taking initiative to resolve problems is required.
• Solid knowledge of WHODrug and MedDRA coding dictionaries is required.
• Knowledge of current technological developments/trends in clinical trial design and statistical methodology is required.
• Excellent verbal and written communications skills are required. 
• Excellent computer literacy skills with expertise in Microsoft Office are required.
• Experience with preparing statistical analyses (e.g., CSR, ISS, ISE) for regulatory submission is desirable.

Organizational Overview:

IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Our mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Through scientific and clinical research in Africa, India, Europe, and the U.S., IAVI is pioneering the development of biomedical innovations designed for broad global access. We develop vaccines and antibodies in and for the developing world and seek to accelerate their introduction in low-income countries. IAVI programs and partnerships are grounded in the regions of the world where the disease burden is the greatest, and our approach emphasizes sustainability. Our network of clinical research center partners in Africa and India helps strengthen in-country research capacity and supports the training and education of the next generation of scientists. The global impact of our science includes fundamental contributions to understanding the biology of HIV infection, which IAVI and others are applying toward advancing vaccine science and immunology. IAVI accelerates scientific discovery and development by fostering unique collaborations among academia, industry, local communities, governments, and funders to explore new and better ways to address public health threats that disproportionately affect people living in poverty. Our global reach, including a clinical research network in five countries in sub-Saharan Africa and in India, has allowed us to make fundamental contributions to understanding the epidemiology, transmission, virology, and immunology of HIV. This work played a key role in facilitating the design of promising HIV vaccine candidates, as well as the discovery of broadly neutralizing antibodies that are now being advanced as promising approaches for HIV prevention. Our integrated capabilities in vaccine and antibody discovery, development, and clinical research take advantage of bio-pharmaceutical industry expertise to accelerate the development and testing of prevention methods for HIV and other diseases. Through the Product Development Center, we support external researchers with technical and scientific expertise to accelerate the development of their own products.

 
Disclaimer: Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities and skills required of personnel so classified. This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship. IAVI is an equal opportunity employer and applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. 

IAVI IS AN EQUAL OPPORTUNITY EMPLOYER actively committed to fostering a diverse and inclusive global organization. IAVI believes that diversity and inclusion among our teammates is critical, and we seek to recruit, develop and retain the most talented people from a representative candidate pool. At IAVI, we celebrate the spectrum of colleagues’ experiences and believe that dedication to our mission above all is essential to our success as a scientific global non-profit. IAVI upholds these principles through IAVI’s Global Diversity and Inclusion Committee.

IAVI has zero tolerance for discrimination or harassment on the basis of race, color, ethnicity, caste, national origin, home language, ancestry, religion, marital or civil partnership status, age, physical or mental disability, HIV status and any other medical condition, genetic information, pregnancy, sexual orientation, gender identity or expression, and veteran status, in addition to any other status protected under the law in any of our locations worldwide.