Principal Biostatistician

Precision For Medicine; United States; On-site; USD 133,000 - 180,000; Full time

Job summary

A leading company in the clinical development sector is seeking a skilled Biostatistician to provide statistical support across all phases of clinical trials. The role involves developing statistical methods, conducting analyses, and collaborating with project teams. Candidates should have a Master's or PhD in Statistics/Biostatistics, with extensive experience in SAS programming and a strong grasp of statistical principles. This is a full-time position offering a competitive salary and benefits.

Benefits

Health Insurance

Retirement Savings Benefits

Life Insurance

Disability Benefits

Parental Leave

Paid Time Off

Qualifications

• Master's or PhD in Statistics/Biostatistics with 7-10 years experience.
• Experience with SAS and advanced statistical concepts.

Responsibilities

• Develop and review statistical methods for clinical study protocols.
• Generate analysis datasets and perform quality control for SAS programs.
• Lead statistical activities for studies within timelines.

Skills

SAS

Statistical Principles

Problem Solving

Communication

Organizational Skills

Education

Master's degree in Statistics

PhD in Statistics

Job description

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:

• Develop and review statistical methods of the clinical study protocol including complex study designs
• Provide and/or verify sample size calculations. Perform 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, figure and listing shells, complex 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 SAS
• Perform 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 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-related project components
• Interact directly with study team
• Interact directly with sponsors
• Lead all statistical activities for study within timelines
• Independently perform budget health review on projects and review monthly invoices
• Perform oversight 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 related field with 10+ years experience; PhD degree in Statistics, Biostatistics, or related field with 7+ years experience

Other Required:

• Experience with SAS
• 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 SAS programming skills and familiarity with other packages
• Outstanding statistical skills
• Excellent 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 skills
• Excellent presentation skills
• 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 all times to promote the image of Precision, acting as an ambassador to the Company
• Ensure that all internal systems are routinely updated as appropriate (e.g., timesheets, expense reports, financial reports, etc.)

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

Reasonable estimate of the current range: $133,000 USD - $180,000 USD

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 ourCA 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 [e-mail].

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 extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Technology, Information and Internet

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