Senior Statistical Scientist

Company: Actalent
Location: Cleveland
Posted on: March 20, 2023

Job Description:

MUST HAVE: experience with Bayesian methods, Real World Data, EMR/EHR, and CRO.Description:As an active team member of the Statistical Consulting and Research team, perform consultancy tasks in a diverse range of projects involving study design, data analysis, modeling and inference, expert testimony, regulatory guidance. Serve as the face of the company and main point of contact for clients in the design of clinical trials and other scientific projects requiring methodological input or requiring expert statistical support.Provide expertise in one or more of the following areas: Experimental design - Bayesian methods - Adaptive design - Validation of diagnostic tests, devices, and/or biomarkers - Missing data, multiple imputation - Historical controls - Rare and orphan diseases - Regulatory pathways - Support internal operational teams in their implementation of studies and methods, including mentoring on complex protocols and area of expertise - Assess the developmental status of new projects and identify clients' needs - Lead or contribute to efforts to publish (posters, presentations, manuscripts) in area of expertise and maintain active membership in key scientific societies (e.g., International Biometric Society, Society for Clinical Trials) - Write and review statistical sections of protocols, including performing sample size and power calculations addressing unique and challenging situations - Prepare reports summarizing consultancy findings, such as statistical modelling of endpoint selection and other study design features - Develop SAS or R programs to perform modelling and ad hoc analyses - Develop and maintain state-of-the-art knowledge on advanced statistical methods and standard practices in clinical trials - Review statistical and clinical reports, including NDA, IND, BLA, and other relevant submission package materials - Support clients in their preparation for meetings and other interactions with regulatory health authorities, such as the EMA and FDA - Participate in business development activities to support the successful conversion of prospects into clients, including assisting in the identification and assessment of new opportunities and writing technical/research strategy sections of proposals and applications - Serve as the voting member statistician on industry- and government-sponsored IDMCs for randomized clinical trialsAdditional Skills & Qualifications:Master's degree or Doctorate (PhD, ScD, DrPH) in (Bio)Statistics, or Master's degree or Doctorate in another quantitative science with substantial coursework in statistics At least 5 years of experience in clinical biostatistics Fluent English Experience serving as a point of contact for clients Excellent interpersonal skills (proven communication, organizational and time management, and flexibility) Passionate about science and clinical research Motivation and ability to build client partnerships Knowledge of Good Clinical Practice and regulations governing clinical trials and electronic data Trained in SAS and R programming Experience using sample size and other statistical software (e.g., PASS, EAST) Impeccable attention to detail Ability to work independently Team player Problem solver Flexible to travelYou can send your resume directly to Gavin at About Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Cleveland , Senior Statistical Scientist, Other , Cleveland, Ohio