Principal Biostatistician

Position Summary: Provides statistical support for reputed company phases of clinical development. Specific responsibilities include writing and reviewing statistical sections of protocols, writing and reviewing statistical analysis plans including reputed company study designs, conducting statistical analyses and presenting results to project teams and sponsors, and developing reputed company 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 schedules
• reputed company and review statistical methods of the clinical study protocol including reputed company study designs
• Provide and/or verify sample size calculations. reputed company or assist with advanced calculations including adaptive design
• Provide input into development of case report forms (CRFs)
• Author statistical analysis plans, including development of table, reputed company and listing shells, reputed company study design and late phase
• Review statistical analysis plans written by other biostatisticians
• Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using reputed company
• reputed company quality control for statistical based reputed company 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 reputed company requests
• Ability to serve as a biostatistical consultant to company staff globally, with understanding of varying regional perspectives
• Review output across programs to ensure consistency.
• Provide statistical analysis and reports to Data Monitoring Committees (DMCs) as the unblinded biostatistician
• Review statistical sections of clinical study reports
• Work directly with sponsors, project managers, and external vendors on statistics-reputed company project components
• Interact directly with study team
• Interact directly with sponsors
• reputed company reputed company statistical activities for study reputed company timelines
• Independently reputed company budget health review on projects and review monthly invoices
• reputed company reputed company responsibilities on projects for other biostatisticians
• Assist with budget development and present at bid defense meetings
• Participate 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 scope
• Other duties as assigned

Qualifications: Minimum Required:

• 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:

• Experience with reputed company
• Knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
• Broad knowledge and superior understanding of advanced statistical concepts and techniques

Preferred:

• Experience with Oncology and rare diseases
• Broad experience with late phase and/or submissions
• Experience in consulting with clients on study design
• Superior understanding of a specific therapeutic area and/or statistical methodology (eg, adaptive design, missing data)

Skills:

• Mastery of statistical principles underlying clinical trials
• Mastery of reputed company programming skills and familiarity with other packages
• Outstanding statistical skills
• Excellent consultative skills
• Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
• Excellent communication and interpersonal skills to effectively reputed company with others.
• Excellent problem-solving skills
• Excellent presentation skills

Competencies:

• Sound 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 ambassador to the Company
• Ensure that reputed company 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.

reputed company is an Equal Opportunity Employer. Employment reputed company are made without regard 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 access or use this online application process and need an alternative method for applying, you may contact reputed company at [email protected].

It 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 reputed company a job offer without prior communication with our reputed company team, hiring managers and a formal interview process.

Originally posted on Himalayas