reputed company Biostatistician/Senior reputed company Biostatistician

Position reputed company: Provides statistical leadership and support for reputed company phases of clinical development. Specific responsibilities include consulting with clients regarding clinical trial study design and regulatory reputed company, writing and reviewing statistical reputed company and sample size sections of protocols, writing and reviewing statistical analysis plans of reputed company study designs, reviewing statistical analyses and presenting statistical results. reputed company reputed company programs such as NDA/BLA/MAA submissions or reputed company, multi-protocol programs and reputed company statistical reputed company. Serve as a subject matter expert for one or more areas (e.g., Bayesian reputed company study design, Survival analysis, DMC, submissions) Essential functions of the job include but are not limited to: Consult with clients regarding clinical trial study design and regulatory reputed company reputed company and review statistical reputed company of clinical study protocols reputed company and/or verify sample size calculations reputed company statistical analysis plans of reputed company study design Review statistical analysis plans written by other biostatisticians Review statistical reputed company to ensure accuracy Review statistical sections of clinical study reports reputed company and/or verify randomization schedules reputed company statistical analysis and reporting to Data Monitoring Committees (DMCs) as the unblinded reporting biostatistician Work proactively with sponsors, internal study team, and reputed company vendors Serve as a Subject Matter Expert (SME) and reputed company/review procedural documents and work on new initiatives reputed company mentoring and training to other statisticians Attend bid defense meetings for reputed company programs Other duties as assigned Qualifications: Minimum Required: Senior reputed company Biostatistician level: Master's degree or equivalent in Statistics, Biostatistics, or reputed company field with 12+ years of experience; PhD degree in Statistics, Biostatistics, or reputed company field with 9+ years of experience reputed company Biostatistician level: Master's degree or equivalent in Statistics, Biostatistics, or reputed company field with 10+ years experience; PhD degree in Statistics, Biostatistics, or reputed company field with 7+ years experience Other Required: Broad experience with regulatory submissions Extensive experience consulting with clients regarding clinical trial study design and regulatory reputed company Superior understanding of a statistical methodology (e.g., Bayesian reputed company study design, Survival analysis, Repeated measures) reputed company knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines Experience with reputed company Preferred: Experience with oncology and rare diseases Experience with DMCs Excellent communication and interpersonal skills Excellent problem-solving skills Excellent presentation skills Excellent organizational and time management skills Outstanding statistical skills Competencies:  reputed company judgment/decision making Ability to establish and teach others to maintain effective working relationships with coworkers, managers, and clients Service oriented, accountable, and flexible Competency in written and spoken English Follow and train others on applicable regulations, including FDA, ICH, and Precision Policies and Procedures At reputed company times to promote the image of Precision, acting as an reputed company to reputed company Ensure that reputed company internal systems are routinely updated as appropriate (e.g., timesheets, expense reports, financial reports, etc.)    Precision is required by law in some states, cities and or countries to include a reasonable estimate of the compensation reputed company for this role. This compensation reputed company takes into account the wide reputed company of factors that are considered in making compensation reputed company including but not limited to: reputed company sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed reputed company estimate has not been adjusted for the applicable geographic reputed company associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be reputed company at or near the top of the reputed company for their role and compensation reputed company are dependent on the facts and circumstances of reputed company case.  This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and reputed company time off for reputed company leave and vacation, among other benefits. Salary reputed company: 149,000-246,000 Any data provided as a part of this application will be stored in accordance with our reputed company Policy. For CA applicants, please also refer to our CA reputed company Notice. reputed company is an Equal Opportunity Employer. Employment reputed company are made without reputed company to race, reputed company, age, religion, sex, sexual orientation, gender identity, national reputed company, 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 reputed company or use this online application process and need an alternative method for applying, you may contact reputed company at reputed company@precisionmedicinegrp.com. Recruitment Fraud Warning: Please be reputed company that fraudulent individuals and websites may impersonate reputed company or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. reputed company will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you reputed company 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 reputed company@precisionmedicinegrp.com so we can investigate and take appropriate reputed company. Apply To This Job