Durham, United States
Posted on: April 17, 2021
Closing: May 17, 2021
Position Type: Full Time
BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. Oral, once-daily ORLADEYO™ (berotralstat) is approved in the United States and Japan for the prevention of HAE attacks in adults and pediatric patients 12 years and older, and under regulatory review for approval in the European Union. BioCryst has several ongoing development programs including, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, and Korea. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company’s website at www.biocryst.com.
The Director, Biostatistics within BioCryst Pharmaceuticals is responsible for the planning and delivery of statistical activities required to support the highest quality design, conduct, and analysis of BioCryst-sponsored studies. Having both technical and vendor management responsibilities, this role is responsible for the appropriate use of statistical thinking and methods, and conformance to principles of GCP, as applicable to biostatistics and clinical data management. Performance in this role relies on significant experience in clinical study design and programming as well as sound judgment to plan and accomplish goals. In this role, the Director, Biostatistics will serve as the Biostatistics project lead for one or more indications for compounds under study, including input to the drug development and regulatory strategy.
ESSENTIAL DUTIES & RESPONSIBILITIES:
• Provides statistical support as Biostatistics project lead for one or more compounds, including input into design and analysis of clinical trials, vendor oversight, and submission activities. It is anticipated that this person will provide support for one or more indications for compounds under study.
• Ensures the relevance and adequacy of statistical methods employed in BioCryst-sponsored clinical development activities
• Ensures conformance to relevant regulatory guidelines and Good Clinical Practice, as applicable to Biometrics
• Effectively contributes to the formulation of clinical development strategies as regards optimal development program and study design
• Participates in the selection, direction, and supervision/management of CRO/ contract staff for performance of outsourced operational activities, including oversight of statistical programming
• Utilizes statistical software (SAS, NQuery, JMP and/or Prism) for internal ad hoc requests for data analysis, samples sizes, graphics etc.
• Participation in clinical development/product management teams in support of organizational objectives
• Participation in meetings with regulatory agencies such as the FDA
• Participation in organization-wide process definition, creation, and implementation with a continuous focus on efficiency and productivity enhancement
• Monitoring and evaluation of relevant performance metrics
• Author/ reviewer of relevant sections of critical documents required to support development of BioCryst’s products including clinical study protocols, statistical analysis plans, data management plans, regulatory briefing documents, regulatory dossiers such as NDAs and MAAs, responses to regulatory questions, scientific abstracts, and manuscripts
• Responsible for accuracy of all data included in public corporate communications of BioCryst clinical trial results, including press releases, slide presentations, scientific meeting abstracts, and published manuscripts
• Ability to communicate technical concepts to cross-functional partners at BioCryst, to technical and regulatory audiences, and to broader audiences in a nontechnical manner without loss of rigor
• All other duties as assigned
EXPERIENCE & QUALIFICATIONS:
• MS or PhD in Biostatistics (or related field) with at least 5 years’ experience in the pharmaceutical industry, with relevant experience in the design, analysis and interpretation of clinical trials and with sufficient SAS programming experience to support these activities. Prefer at least 10 years’ experience.
• Proven expertise with the disciplines, practices and procedures that pertain to biostatistics, programming, and understanding of clinical data management processes
• Demonstrated knowledge of the clinical development process and of relevant regulatory guidelines and requirements
• Leadership skills both functional and cross functional
• Takes a hands-on approach (e.g. will do analyses him/herself when necessary)
• Excellent written and verbal communication skills
• Proven team player with ability to work well in a collegial environment: willing to challenge the status quo
• Experience in design and analysis of Phase II/III trials.
• Experience providing analyses to data monitoring committees and/or study steering committees
• Experience with regulatory submissions and interactions with regulatory agencies
• Flexible scheduling and ability to travel internationally
• Small company attitude, embraces change within a high-risk environment
• Responsiveness and ability to prioritize effectively
The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.
BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Posted on: April 17, 2021
Closing: May 17, 2021
Position Type: Full Time