Associate Director, Biostatistics - Remote Position

Puma Biotechnology Inc. does not accept unsolicited resumes or candidates from outside staffing agencies or recruiters.

The Associate Director, Biostatistics acts as fully independent Statistical lead responsible for one or multiple drug projects. This person interacts internally with all members and functions of the study and management teams providing support to the projects, and externally as required with regulatory authorities and key opinion leaders. In addition, the senior staff member will be expected to supervise and mentor other statisticians or statistical programmers and is accountable for quality of all Statistical input and deliverables, including adherence to budget and timelines.

Essential Functions

• Provides Statistical input to clinical teams including design of studies and analyses requiring advanced statistical methodologies

• Ensures creation of, maintenance and adherence to indication specific standards with respect to key variables, definitions, Statistical methods, data structures and presentation of results

• Ensures availability of integrated database(s) where needed, and planning and conduct of integrated analyses

• Develops Statistical Analysis plan and statistical section of the protocol Ensures Statistical analyses performed in accordance with the protocol, Statistical analysis plan, good Statistical practice, and available regulatory guidelines

• Provides topline reports of study results and is responsible for the data content of the clinical study report

• Provides adequate vendor oversight of the study deliverables created. For example, ADAM/SDTM datasets and TFLs.

• Perform vendor qualification / audits in collaboration with functional management

• Investigates new Statistical methodology and software and provides feedback to department

• Resource planning and hiring

• Mentors junior level Statisticians and CRO staff

• Develops and maintains work instructions, guidelines and SOPs

Competencies

• Excellent organizational, interpersonal and leadership skills

• Excellent communication skills - Able to clearly communicate Statistical issues to diverse audience

• Keen eye for detail

• Dedication to quality and reliability

• Good negotiation skills

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Required Education & Experience

Required:

• Ph.D. in Statistics

• Minimum of 8 year experience in applying Statistical methods in biomedical research, pharmaceutical or CRO for Oncology trials

• Ability to visualize the big picture as the independent lead Statistician in a regulatory submission

• Knowledge of international regulations (ICH, FDA, EMA)

Preferred:

• Advanced and broad knowledge of Statistical methods, along with understanding of industry practices related to the Statistical analysis of clinical data

• Knowledge of Statistical software

• In-depth familiarity with processes and procedures in data management and SAS programming

Position Type/Expected Hours of Work

This is a full-time position. Days and hours of work are Monday through Friday, 8:30 a.m. to 5 p.m. This position regularly requires long hours and may require weekend work.

Work Environment

This is a full-time position. Days and hours of work are typically Monday through Friday, 8:30 AM to 5 PM. However, this position regularly requires longer work hours, and the ability to be flexible regarding work hours depending on the needs of the business.

Physical Demands

The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.

The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; and talk or hear. The employee must occasionally lift or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.

Travel

Some out-of-area and overnight travel may be expected. Travel may be required (up to 10%).

Compensation Range

The salary range for this role is $175,000 - $205,000 per year. Higher compensation may be available for someone with advanced skills and/or experience.

At Puma Biotechnology, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), an annual bonus target, and a robust benefits package. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

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