Principal Biostatistician

Position Summary:Provides statistical support for all phases of clinical development. Specific responsibilities include writing and reviewing statistical sections of protocols, writing and reviewing statistical analysis plans including complex study designs, conducting statistical analyses and presenting results to project teams and sponsors, and developing SAS programs for tables, listings, figures and analysis datasets in accordance with Precision and/or sponsor procedures or study specific guidelines.Essential functions of the job include but are not limited to:Generate and/or verify randomization schedulesDevelop and review statistical methods of the clinical study protocol including complex study designsProvide and/or verify sample size calculations. Perform or assist with advanced calculations including adaptive designProvide input into development of case report forms (CRFs)Author statistical analysis plans, including development of table, figure and listing shells, complex study design and late phaseReview statistical analysis plans written by other biostatisticiansGenerate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SASPerform quality control for statistical based SAS programs and other study documents (e.g., presentations and reports)Provide or supervise programming and statistical support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requestsAbility to serve as a biostatistical consultant to company staff globally, with understanding of varying regional perspectivesReview output across programs to ensure consistency.Provide statistical analysis and reports to Data Monitoring Committees (DMCs) as the unblinded biostatisticianReview statistical sections of clinical study reportsWork directly with sponsors, project managers, and external vendors on statistics-related project componentsInteract directly with study teamInteract directly with sponsorsLead all statistical activities for study within timelinesIndependently perform budget health review on projects and review monthly invoicesPerform oversight responsibilities on projects for other biostatisticiansAssist with budget development and present at bid defense meetingsParticipate in the development and maintenance of departmental procedures and standards (templates, SOPs, WIs etc.)Review study tasks to ensure study being conducted in line with agreed budget; identify change in scopeOther duties as assignedQualifications:Minimum Required:Master's degree or equivalent in Statistics, Biostatistics, or related field with 10+ years experience; PhD degree in Statistics, Biostatistics, or related field with 7+ years experienceOther Required:Experience with SASKnowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelinesBroad knowledge and superior understanding of advanced statistical concepts and techniquesPreferred:Experience with Oncology and rare diseasesBroad experience with late phase and/or submissionsExperience in consulting with clients on study designSuperior understanding of a specific therapeutic area and/or statistical methodology (eg, adaptive design, missing data)Skills:Mastery of statistical principles underlying clinical trialsMastery of SAS programming skills and familiarity with other packagesOutstanding statistical skillsExcellent consultative skillsExcellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.Excellent communication and interpersonal skills to effectively interface with others.Excellent problem-solving skillsExcellent presentation skillsCompetencies:Sound judgment/decision makingAbility to establish and teach others to maintain effective working relationships with coworkers, managers and clientsService oriented, accountable and flexibleCompetency in written and spoken EnglishFollow and train others on applicable regulations, including FDA, ICH, and Precision Policies and ProceduresAt all times to promote the image of Precision, acting as an ambassador to the CompanyEnsure that all internal systems are routinely updated as appropriate (e.g., timesheets, expense reports, financial reports, etc.)Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected] has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.Originally posted on Himalayas

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