Penfield Search Partners
Contact: Neisha Camacho/Terra Parsons – firstname.lastname@example.org
Job Description: The Contract Biostatistics Director will be responsible for overseeing project and protocol level statistical deliveries. They will work in all phases of clinical drug development and be involved in putting together background documents in support of regulatory meeting requests. The Contract Biostatistics Director will be required to collaborate with external vendors and a broad group of internal functional areas (e.g. project management; clinical science; data management; medical affairs; commercial; chemistry, manufacturing and controls (CMC); and safety/pharmacovigilance).
Essential Duties and Responsibilities:
- Guide the development of the statistical sections of clinical protocols and corresponding statistical analysis plans (SAPs).
- Assist in writing statistical sections of pediatric plans and End-of-Phase background packages to be provided in support of regulatory meetings. This includes evaluating proposed study designs and primary endpoints.
- Collaborate with study team members in defining estimates.
- Analyze data needed to respond to ad-hoc regulatory inquiries in a timely manner.
- Program or QC analyses in support of press releases, investor calls and/or business development activities.
- Perform exploratory statistical analyses for decision making purposes.
- Manage vendor statistical deliverables and timelines.
- Collaborate with external vendors and a broad group of internal functional areas (e.g. project management; clinical science; data management; medical affairs; commercial; chemistry, manufacturing and controls (CMC); and safety/pharmacovigilance).
- MS in Statistics, Biostatistics, or a related field (PhD preferred).
- Minimum 10 years of related experience in clinical biostatistics in the pharmaceutical / biotechnology industry or equivalent.
- Good SAS programming skills.
- Strong understanding of Clinical Development.
- Ability to work in the fast-paced environment of a small biotech company
- Thorough knowledge of design-of-experiments, clinical protocols, sample size computation, multivariate/repeated measures, categorical variable analysis, and the ICH E9 guidance document
- The ability to prioritize and manage multiple competing tasks with overlapping deadlines.
- The capacity to complete their work in an independent manner.
- Experience with the development and validation of patient reported outcomes and clinician reported outcomes.
- Knowledge of Bayesian methods, adaptive clinical trials, causal inference, meta-analysis analyses, multiple imputation techniques, stochastic modeling/simulation, nonlinear mixed effects models and ICH E9(R1) addendum.
- R programming skills.