Job Description
About the position
The Executive Director or Vice President, Biostatistics and Data Management (DM) functions is responsible for all aspects of DM and statistical planning, programming, analysis, and reporting for Savara. Provides direct management of all Savara DM team members as well as high-level oversight of all contract data managers and DM members from CROs. Responsible for identifying and managing all contract statistical CROs and consultants to ensure accurate and timely reporting of results from Savara clinical trials. Responsible for the management of DM and Biostatistics timelines and budgets.
- Responsibilities
- Oversight and high-level management of Savara and CRO DM tasks, resources, and timelines; day-to-day management is the responsibility of the Savara Director of Clinical DM
- Line management of the Director of Clinical DM, including oversight of responsibilities, evaluation of performance, and active support of professional goals/objectives/development
- Support the DM team in the review of data for accuracy, quality, and interpretability, as needed
- Oversight and management of all aspects of statistical planning, programming, analysis, and reporting for the company, including oversight and management of all contract statistical CROs and consultants and review and approval of statistical outputs, such as analysis datasets and tables/figures, and listings (TFLs)
- Serve as author, co-author, or primary reviewer and approver of SAPs, study data standardization plans (SDSPs), and statistical sections of documents
- Perform statistical programming and analysis to validate key analysis datasets and TFLs and to provide statistical outputs for publication purposes or internal planning/decision-making
- Responsible for the determination and monitoring of and necessary adjustments to the annual resourcing and budget for DM and biostatisticst
- Lead role in authoring and/or reviewing the statistics-related sections of the protocol synopsis, clinical study protocols, and relevant sections of the Investigator’s Brochure (IB), regulatory documents, Clinical Study Report (CSR), and other critical clinical study documents, in close collaboration with the Study Responsible Physician (SRP) and in partnership with supporting departments within Savarat
- Leverage scientific background to collect, translate, summarize and draft individual study concepts/strategies into study designs, in collaboration with the SRP, to drive protocol development and/or amendmentst
- Present data internally to stakeholders and externally to academic collaborators through presentations and contributions to publicationst
- Support interactions with relevant stakeholders and partners to facilitate successful conduct of clinical trials including clinical site personnel and CROst
- Provide statistical support to Regulatory Affairs activities for a clinical program (e.g., authoring or reviewing sections of Health Authority documents/responses; participate in Sponsor inspections)
- Collaboration with other members of the department led by the Chief Medical Officer in developing program strategies, planning resources, tracking progress on studies and submissions, and setting departmental objectives and prioritiest
- Represent Savara externally, as neededt
- Other duties as assigned.
- Requirements
- Advanced degree in statistics
- At least 20 years (15 years if with PhD degree) of progressive experience in statistics as applied to clinical studies in the pharmaceutical, biotechnology, or CRO industry
- At least 5 years of experience in the functional management of statistics and DM at the Senior Director level or higher
- Has served as lead statistician on Phase I-IV studies and New Drug Applications (NDAs), Biologics License Applications (BLAs), and/or Marketing Authorization Applications (MAAs) in various therapeutic areast
- Ability to manage external vendors for statistical and data management activities
- Expertise in SAS programming and in-depth knowledge of and practice in applying Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) standards
- Broad knowledge and clear understanding of FDA requirements related to electronic systems and records; strong understanding of guidelines as they relate to DM and statistics, including Good Clinical Practice (GCP) and International Council on Harmonisation for Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelinest
- Benefits
- Highly competitive medical, dental, and vision coverage
- Flexible Spending Account for health care and dependent care expenses and Health Savings Account
- Paid time off and paid holidays, including Dec 24-Jan 1
- Paid parental leave
- 401(k) with highly competitive match
- Life, AD&D, STD and LTD insurance coverage
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