30+ days ago
Leidos Life Sciences ….
This role supports a growing and diverse range of clinical (in people), preclinical (in vitro or in vivo) and nonclinical (animal only) development programs by contributing to the design, data collection, and reporting of studies in a manner consistent with industry standards, applicable regulations and clinical development strategy. The development programs are conducted in partnerships with academia, industry and government agency sponsors. This position assembles, analyzes, interprets, and presents scientific and medical data for eventual reporting to regulatory agencies such as the US Food and Drug Administration. Responsibilities will also include evaluation of clinical outcome measures, data review and trial startup activities. Additional research studies range from prospective clinical trials to retrospective and real world evidence (RWE) studies, novel treatment modalities and combination products, validation of biomarkers, and artificial intelligence (AI) algorithm development and validation.
Based on these strategic objectives, Leidos Life Sciences is seeking a Biostatistician to provide support to the Life Sciences Organization (LSO) clinical research team in Frederick, MD.
+ Provide statistically sound preclinical and clinical study design enabling data analyses. Working with Contract Manufacturing Organizations (CMO) and medical directors, contribute to the development of clinical protocols/amendments by performing literature review/analysis and soliciting input from medical, statistical and operational, as well as preclinical, resources.
+ Ensure clinical data collection proceeds in a manner consistent with strategic objectives and regulatory requirements for reporting (i.e., produce statistical analysis plans and data displays; provide input to case report form [CRF] design and data management processes; perform periodic review and analysis of clinical data).
+ Participate in planning for interim data analyses and reviews, including Data Safety Monitoring Board (DSMB) meetings.
+ Working with the medical director, medical monitor to evaluate emerging clinical data.
+ Evaluate inter- and intra-laboratory comparisons of raw data, study endpoints, measurement reproducibility, treatment effects (parametric and non-parametric), and bioequivalence.
+ Analyze measures of intra- and inter- assay variability and inter-treatment differences for novel and industry-standard measures of drug efficacy and toxicity.
+ Determine statistical significance of animal model efficacy, toxicity, survival, protection, and lethality endpoints.
+ Provide expertise related to designing, developing and conducting statistical analyses and interpretation for clinical and pre-clinical studies. Review/interpret data to produce strategically relevant abstracts, presentations and manuscripts.
Author (and/or work with medical writer to develop) clinical documents including but not limited to: clinical/preclinical protocols, briefing documents, Investigational New Drug (IND) annual reports, Investigator's Brochures, clinical protocols and amendments, clinical/preclinical study reports, scientific proposals, scientific manuscripts and abstracts, posters and scientific presentations.
+ Strong analytical mind, excellent written/verbal communication skills, attention to detail, organizational skills, and ability to work independently and as part of a team.
+ Strong document management skills, including proficiency with MS Word, EndNote, Excel, and PowerPoint.
+ Strong medical writing skills: takes ownership of document, organizes timeline, works with other co-authors, resolves discrepancies and edits to achieve consistency, uses precise accurate language and grammar.
+ Knowledge and experience in clinical development.
+ Knowledge and experience in preclinical development is desirable.
+ Ability to multitask to meet timelines under changing conditions.
+ Master’s degree in Statistics required, PhD a plus;
+ Demonstrated experience in SAS, R programming and data collected through an EDC?;
+ 5-10 years of experience in clinical research setting, including medical writing responsibilities and oversight of (or close collaboration with) data management/analysis/reporting functions.
+ Experience authoring clinical protocols, regulatory documents (IND sections, clinical study reports, Investigator’s Brochures), as well as scientific publication and presentations.
External Referral Bonus:Ineligible
External Referral Bonus $:
Potential for Telework:No
Clearance Level Required:None
Scheduled Weekly Hours:40
Pay Range: REQNUMBER: R-00060874
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an equal opportunity employer/disability/vet.