Principal Biostatistician

p strong Position Summary: nbsp; /strong /p p strong Job Description nbsp; /strong /p p 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. nbsp; /p p strong Essential functions of the job include but are not limited to: nbsp; /strong /p ul li Generate and/or verify randomization schedules nbsp; /li li Develop and review statistical methods of the clinical study protocol including nbsp; complex study designs nbsp; /li li Provide and/or verify sample size calculations. Perform or assist with advanced nbsp; calculations including adaptive design nbsp; /li li Provide input into development of case report forms (CRFs) nbsp; /li li Author statistical analysis plans, including development of table, figure and listing nbsp; shells, complex study design and late phase nbsp; /li li Review statistical analysis plans written by other biostatisticians nbsp; /li li Generate analysis datasets, tables, figures, and listings to support the analysis of nbsp; clinical trials data using SAS nbsp; /li li Perform quality control for statistical based SAS programs and other study documents nbsp;(e.g., presentations and reports) nbsp; /li li Provide or supervise programming and statistical support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests /li li Ability to serve as a biostatistical consultant to company staff globally, with nbsp; understanding of varying regional perspectives nbsp; /li li Review output across programs to ensure consistency. /li li Provide statistical analysis and reports to Data Monitoring Committees (DMCs) as the unblinded biostatistician /li li Review statistical sections of clinical study reports /li li Work directly with sponsors, project managers, and external vendors on statistics related project components. Interact directly with study team /li li Interact directly with sponsors /li li Lead all statistical activities for study within timelines /li li Independently perform budget health review on projects and review monthly invoices /li li Perform oversight responsibilities on projects for other biostatisticians /li li Assist with budget development and present at bid defense meetings /li li Participate in the development and maintenance of departmental procedures and nbsp; standards (templates, SOPs, WIs etc.) /li li Review study tasks to ensure study being conducted in line with agreed budget; nbsp; identify change in scope /li li Other duties as assigned nbsp; /li /ul p strong Qualifications: nbsp; /strong /p p strong Minimum Required: nbsp; /strong /p ul li Master's degree or equivalent in Statistics, Biostatistics, or related field with 10+ years nbsp;experience; PhD degree in Statistics, Biostatistics, or related field with 7+ years nbsp;experience nbsp; /li /ul p strong Other Required: nbsp; /strong /p ul li Experience with SAS nbsp; /li li Knowledge of industry standards such as the ICH guidelines, CDISC data structures, nbsp;21 CFR Part 11, and FDA guidelines nbsp; /li li Broad knowledge and superior understanding of advanced statistical concepts and nbsp;techniques nbsp; /li /ul p strong Preferred: nbsp; /strong /p ul li Experience with Oncology and rare diseases nbsp; /li li Broad experience with late phase and/or submissions nbsp; /li li Experience in consulting with clients on study design nbsp; /li li Superior understanding of a specific therapeutic area and/or statistical methodology nbsp; (eg, adaptive design, missing data) nbsp; /li /ul p strong Skills: nbsp; /strong /p ul li Mastery of statistical principles underlying clinical trials nbsp; /li li Mastery of SAS programming skills and familiarity with other packages nbsp; /li li Outstanding statistical skills nbsp; /li li Excellent consultative skills nbsp; /li li Excellent organizational skills, time management, and ability to coordinate workload nbsp;and meet established deadlines. nbsp; /li li Excellent communication and interpersonal skills to effectively interface with others. nbsp; /li li Excellent problem-solving skills nbsp; /li li Excellent presentation skills strong nbsp; /strong /li /ul p strong Competencies: nbsp; /strong /p ul li Sound judgment/decision making nbsp; /li li Ability to establish and teach others to maintain effective working relationships with coworkers, managers and clients /li li Service oriented, accountable and flexible /li li Competency in written and spoken English /li li Follow and train others on applicable regulations, including FDA, ICH, and Precision Policies and Procedures nbsp; /li /ul div class= content-conclusion hr p Any data provided as a part of this application will be stored in accordance with our nbsp; a href= https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fprivacy-policy%2F amp;data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C amp;sdata=9DgboiHTFPrNYVhdKhyfdwVyNYwUvZbP%2FroLdWIIfxw%3D amp;reserved=0 Privacy Policy. /a nbsp;For CA applicants, please also refer to our nbsp; a href= https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fca-applicants-privacy-notice%2F amp;data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C amp;sdata=tfAqqMZsG%2B11IchL45HFFVbfECCkYqQpNr0PQxrMFJU%3D amp;reserved=0 CA Privacy Notice /a . /p p 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. /p p 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 a ---------- p span data-teams= true strong Recruitment Fraud Warning: /strong Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at a id= menur2oq class= fui-Link ___1q1shib f2hkw1w f3rmtva f1ewtqcl fyind8e f1k6fduh f1w7gpdv fk6fouc fjoy568 figsok6 f1s184ao f1mk8lai fnbmjn9 f1o700av f13mvf36 f1cmlufx f9n3di6 f1ids18y f1tx3yz7 f1deo86v f1eh06m1 f1iescvh fhgqx19 f1olyrje f1p93eir f1nev41a f1h8hb77 f1lqvz6u f10aw75t fsle3fq f17ae5zn ----- ----- so we can investigate and take appropriate action. /span /p p span data-teams= true strong span data-olk-copy-source= MessageBody Candidates must be legally authorized to work in the country of employment without employer sponsorship. /span /strong /span /p /div Find more English Speaking Jobs in United Kingdom on Arbeitnow