Exec. Director, Statistical Programming

COMPANY:

At BioCryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable protein therapeutics. Our global headquarters is in Durham, North Carolina, we have a regional office in Boston, Massachusetts, and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com or follow uson LinkedIn and Instagram.

JOB SUMMARY:

The Executive Director, Statistical Programming within BioCryst Pharmaceuticals is responsible for leading the statistical programming group at BioCryst.  This includes providing oversight of statistical programming activities for all BioCryst clinical trials, including both in-house and outsourced activities.  Examples of programming activities include analyses for submission to regulatory agencies, exploratory work to support safety review and other activities, and analyses to support scientific publications and medical affairs.

He/she must be a strong leader with extensive experience in the use of SAS software for analysis of clinical trial data and thorough knowledge of CDISC standards. Having both technical, line management and vendor oversight responsibilities, the person in this role is responsible for statistical programming strategy, conduct of analyses, and conformance to principles of GCP as applicable to biostatistics, statistical programming, and clinical data management. An understanding of how SAS programming can be used to support data management activities would be needed.  Performance in this role relies on significant experience in analysis of clinical trial data as well as sound judgment to plan and accomplish goals in a small-company environment.

ESSENTIAL DUTIES & RESPONSIBILITIES:

•       Responsible for developing a vision and strategy for statistical programming group at BioCryst

•       Responsible for Biometrics and Data Science group’s software and systems needs, in partnership with Information Technology.

•       Manages a group of statistical programmers and ensures the team has the best technical capabilities for managing complex algorithms and sophisticated regulatory submission packages.

•       Keep abreast of industry best practices and standards used

•       Participates in capacity planning, including planning for departmental growth as well as increases in capability for in-house programming

•       Ensures that all clinical study teams have a statistical programming lead and that consistent support is provided to each team. 

•       Ensures the completeness, accuracy and timeline of statistical programming employed in BioCryst-sponsored clinical development activities and selected nonclinical studies.

•       Ensures oversight of statistical programming for outsourced trials and regularly meets with CRO counterparts.

•       Ensures consistent and quality review of the following items by statistical programming: eCRFs, annotated CRFs, data management plan, edit check specifications, and statistical analysis plan, with a view to ensuring that data required for specified analyses will be collected, clean, and can be appropriately analyzed. 

•       Ensures accurate programming of internally-produced tables, listings, figures

•       In collaboration with data management, ensures clinical data conformance to relevant regulatory guidelines and Good Clinical Practice.  For example, may provide specialty SAS programming for data management customized line listings to support review of clinical trial data. 

•       Ensures training and support is provided for programmers, medical monitors, scientists, and writers with internal data review tools.

•       Participates in the selection, direction, and supervision/management of CRO/contract staff for performance of outsourced statistical programming activities.

•       Ensures that study documentation is maintained to the standard required according to SOPs and acceptable for audit.

•       Participation in organization-wide process definition, creation, and implementation with a continuous focus on efficiency and productivity enhancement.  Responsible for authoring SOPs related to statistical programming.

•       Monitoring and evaluation of relevant performance metrics.

•       Ability to communicate technical concepts to technical or regulatory audiences, and to broader audiences in a nontechnical manner without loss of rigor. 

•       Other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

•       M.S. in Biostatistics, Computer Science or related field with at least 15 years’ experience in the pharmaceutical industry, with relevant experience in the analysis of clinical trial data or an equivalent combination of education and experience. Incumbent must have extensive SAS programming experience to support these activities.

•       Prior experience in NDA/BLA submissions to successfully support product approvals

•       Prior experience in managing permanent staff

•       Experience with SAS/Graph and/or providing quality graphics for scientific publications.

•       Experience in early phase clinical trials including understanding of clinical pharmacology endpoints would be helpful but is not required. 

•       Understanding of 21CFR Part 11 standards.

•       Experience with tools to support viewing of data by medical monitors and others. 

•       Prior experience with managing outsourced statistical programming work.

•       Proven expertise with the disciplines, practices and procedures that pertain to statistical programming and understanding of clinical data management processes. 

•       Demonstrated knowledge of the clinical development process and of relevant regulatory guidelines and requirements.

•       An understanding of the roles and responsibilities of related disciplines including Biostatistics and Data Management.  Knowledge of clinical database design would be helpful. 

•       Leadership skills both functional and cross functional.

•       Takes a hands-on approach (eg, 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.

•        “Small-company attitude” that 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

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