The Contract Biostatistician is expected to execute many of his/her responsibilities independently, and to have external interactions with regulatory authorities, cooperative groups, external experts, and vendors in support of CD work progress.
The successful candidate will
Participate in a number of new drug development programs as subject matter expert, and provide strategic and technical leadership in the design, execution of clinical development plans, clinical trials, and statistical analysis plans.
Serve as biostatistics program lead for assigned compound(s) and/or study biostatistician.
Manage and oversee biostatisticians working on studies within his/her assigned compound(s) to insure timely and high-quality biostatistics deliverables.
Monitor project progress and insure proper resource allocation for successful project deliverables against goals and timelines.
Be responsible for planning and developing budget, and managing resources and expenses accordingly.
Work with the Clinical Development group to provide input to study design and the statistical section of clinical trial protocols.
Oversee production of, contribute to or prepare statistical sections of protocols, and statistical analysis plans.
Participate in planning for FDA/EMA meetings and preparation of associated responses.
Generate and/or verify sample size calculations and randomization schemes as needed.
Perform quality control checks of statistical analyses and SAS programs, as needed.
Provide guidance to Biostatisticians and Statistical Programmers on SDTM/ADaM and TLFs specifications development and programming.
Provide input to database requirements and work closely with Clinical Data Manager to insure data quality standards are met.
Work as part of a collaborative, cross-functional team with members from other disciplines.
Be responsible for vendor management for statistical, programming, and database functions.
Participate in other activities and meetings to support Biostatistics and the Development Team as necessary.
PhD.in Biostatistics or related field with at least 10 years of directly related experience in the pharmaceutical/biotech industry, or Master’s Degree with at least 13 years of directly related experience.
Experience working on all phases of clinical trials (Phase 3 international clinical trials is a plus).
Experience working on NDA/BLA/MAA development and submissions, including hands-on experience working on ISS/ISE.
SAS programming expertise.
Understanding of ICH GCP as well as knowledge of industry practices and standards.
Strong written and oral communication and presentation skills.
Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint, Project).
Experience working on trials in CNS therapeutic area (Neuropsychological cognition testing in particular) is a plus.
Familiarity with CDISC/SDTM/ADaM data standard specifications.
Adaptive and Bayesian design experience is a plus.
People, projects and vendor management experience is a plus.
Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
Excitement about the vision and mission of Sage.