We are seeking a highly motivated and creative individual to join the Adela team. This is an exciting opportunity to be part of a growing, dynamic, and collaborative company delivering cutting-edge genomic technology directly to clinicians. The Head of Biometrics will lead and manage the Biostatistics and Data Management (BDM) department to ensure that BDM project responsibilities are completed in an accurate and timely manner consistent with SOPs and within budgetary constraints. This individual will also provide input into Adela’s clinical development strategy and participate in the company's interaction with regulatory authorities. This role directs the design, development, modification, and evaluation of a technical infrastructure to expedite the operation and evaluation of clinical trials. Designs and implements experiments and statistical analyses of varying complexity in the context of research, development, product validations, clinical trials and scientific publications. Manages the design, monitors the statistical analysis, and develops tracking systems to determine the efficiency of BDM functions. Must have expertise in state-of-art data manipulation and statistical analysis. Selects, develops, manages, and evaluates personnel to ensure the efficient operation of the department. This position reports to the Chief Medical Officer.
Responsibilities as follows, but not necessarily limited to:
● Drives design and execution of statistical studies with a focus on innovative and efficient quantitative decision making.
● Leads protocol development with expertise on appropriate clinical trial designs
● Interact with clinical investigators and other site personnel (protocol training, professional meetings, data standards)
● Collaborate within and outside Adela to determine optimal study objectives and endpoints consistent with product development plans
● Represent Adela before FDA and world-wide regulatory bodies
● Be familiar with relevant new designs and analyses from available literature
● Lead/support manuscript preparation for professional meetings and peer-reviewed journals
● Develop and write standard and novel statistical analysis plans
● Determine sample size according to company needs and acceptable risk
● Lead statistical modeling expertise and conduct simulations in support of clinical trial designs, product development, and scientific discovery.
● Verify data accuracy and validity
● Prepare data summaries, displays and listings
● Conduct ad hoc and post hoc exploratory data analyses
● Discover data trends and correlations
● Assure compliance with regulatory standards and guidance documents
● Develop departmental SOPs for statistical analysis, statistical programming, database design, database management and data acquisition
● Manage statisticians, SAS programmers, and data management staff
● Develop, train, and mentor direct reports
Skills and Qualifications
● Expert knowledge of advanced statistical methods including the ability to produce novel methods based on first principles understanding.
● Ph.D. in Statistics, Biostatistics or equivalent with 12+ years of relevant experience (or MS with 5+ years) in academia or industry
● Strong knowledge of theoretical / applied statistics and modeling techniques
● Outstanding verbal, writing, and presentation skills with a strong ability to influence
●Proven track record of success in supporting large-scale clinical trials as biostatistician
● Demonstrated success leading the statistical modeling work and publishing the results in academia or industry
● Strong track record of posters/presentations and publications is strongly desirable ● Proficient in R or SAS
● Ability to work independently on multiple concurrent projects in a fast-paced environment
● Strong team player with a demonstrated track record of success in the cross-functional team environment