Oversees the design, development, and implementation of high performance, innovative biostatistics, data management and Statistical Analysis Systems (SAS) programming workflows and provides technical leadership and supervision of a multidisciplinary team. Oversees planning and execution of data management, biostatistics and SAS programing activities in support of clinical trials, regulatory approval, and marketing efforts. Responsible for the overall quality of all Statistics /SAS programming/Data Management design, analysis and reporting deliverables.
- Develops and implements the vision to support research & development, pre-clinical and clinical data management and analysis.
- Oversees advanced biometrical, statistical, and technical activities for data management, analysis and interpretation of statistical data and SAS Programming.
- Provides strategic thinking and expertise to define the right questions to be answered in the design of clinical trials; specifically contributes from a biometrics perspective to the creation of the Clinical Development Plans.
- Directs the design, development, modification and evaluation of a technical infrastructure to expedite the management, evaluation and reporting of clinical trials data.
- Manages the design and monitors processes for clinical data management and reporting
- Manages the design, monitors the statistical analysis and develops tracking systems to determine the efficiency of clinical trials. Manages the evaluation and design of clinical data statistics.
- Responsible for leading the biometrics department teams in ensuring effective, timely, high quality and compliance management and delivery of goals and accountabilities of multiple ongoing projects.
- Ensures all department work is performed consistent with Good Clinical Practices (GCP), International Conference on Harmonisation (ICH), 21 CFR part 11, internal SOPs and training, and international regulatory requirements.
Minimum of a Master's degree in (bio) statistics or related field, an equivalent combination of relevant education and applicable job experience may be considered. Minimum of 20 years progressively responsible experience in clinical research with a focus on biometrics disciplines and 10 years' in a leadership role. Experience includes managing data management, biostatistics and SAS programing professionals on clinical trials and/or clinical research projects that have delivered the agreed-upon end products on time, and prior guidance of lower level or less experienced staff. Biopharmaceutical industry experience required.
- Solid knowledge of data management, statistical and SAS programming processes and technologies.
- Thorough experience with the drug development process and execution on biometrics deliverables.
- Ability to consistently demonstrate leadership qualities in a variety of settings and through multiple experiences and ability to manage project responsibilities independently across a variety of different projects.
- Excellent interpersonal communication and networking skills with the ability to build cross functional bridges.
- Established track record in delivering biometrics components of the clinical projects and regulatory submissions.
- Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization.
- Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals.