Senior Director Biostatistics
Essential functions and responsibilities include the following:
- Oversees statistical strategy and provides statistical support for all clinical programs. Collaborates with clinical and regulatory leads in defining general strategic approach, creating clinical development and statistical plans (CDP and SAP), and producing individual protocols.
- Works independently, or with other statistical departmental members or Biometrics personnel at CROs, to develop effective statistical approaches applicable to project
- Contributes to the design of clinical trials, including statistical sections of the study protocol, randomization methodology, etc.
- Oversees execution of or conducts statistical analyses, prepares statistical methods and results sections for clinical study reports (CSR), and production of overall summaries such as NDA documents S.
- Generates, reviews and approves key results and statistical conclusions. Provides guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package.
- Plans and tracks project activities, timelines, and resource use across projects. Maintains awareness of industry standards, regulatory requirements, and departmental guidelines and SOP
- Provides project support through the specification/review of tables, figures and listings shells, and the writing/review of CDISC (SDTM and ADaM) datasets
- Works with the SAS Programming team to coordinate the reporting of the results of clinical trial.
- Participates in the quality control review of the output form the CRO or internal team.
- Makes statistical contributions to manuscripts for publication / presentation
- Develops and directs Data Management activities by own experience and by overseeing internal or external data management personnel.
- Builds, leads and directs a fully integrated team of Biometrics and Data Management personnel within the organization or external contractors or CRO personnel.
Required Education and Experience
- MS or Ph.D. in Biostatistics, Statistics, or closely related field.
- 10+ years of experience in design and analysis of clinical trials
- Thorough experience with statistical data analysis of clinical pharmaceutical trials (Phase 1-3) as well as integrated data analyses of safety and efficacy. Previous experience on regulatory submissions such as NDA strongly preferred
- Ability to develop and lead statistical strategy for all clinical programs in the company
- Has effectively overseen and collaborated with a fully integrated team comprised of biostatistics, programming, data analysis, and data management. Needs to have the ability to build and lead a fully integrated team of Biometrics and Data Management
- Solid experience in providing leadership, oversight & management of biostatistical, programming, and data management services provided by CROs
- Broad knowledge as well as deep understanding of advanced statistical concepts and techniques, pharmaceutical clinical development and lifecycle management
- Solid knowledge of statistical regulatory guidance and standards (e.g., FDA, ICH and EMA)
- Excellent technical skills in Biostatistics including strong knowledge of the CDISC SDTM and ADaM models, Proficiency in SAS, R and other relevant statistical analysis software systems.
- Experience in the following therapeutic disease areas is preferred but not a must: Inflammatory diseases, Rheumatology, Nephrology
- Outstanding business presence to effectively represent Biostatistics in interaction internally and externally, e.g. with senior management of the organization, cross-functional committees, Key Opinion Leaders, etc.
- Solid experience in representing biostatistics in face-to-face meetings with regulatory authorities
- Excellent written and verbal communication. Ability to communicate complex statistical matters effectively to all program team members as well as to Senior Management.
- Excellent analytical, problem solving and organization skills.
- Ability to influence others, at all levels of the organization, even without direct hierarchical authority, and affect change across organizational boundaries.
- Ability to collaborate effectively with peers, within global teams and in communicating with senior leadership.
- Must be a strong leader that creates vision for the group and who is able to inspire and motivate team members. Takes stand on important issues in a productive, respectful way.