Offer summary

Qualifications:

MS degree in statistics, biostatistics, or mathematics with at least 6 years of industry experience., Extensive knowledge of industry standards such as ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines., Proficiency in SAS programming and statistical methods applicable to clinical trials., Experience with oncology and rare disease studies, and submission processes is preferred..

Key responsibilities:

Lead biostatistics efforts for specific projects, including reviewing protocols and developing analysis plans.

Manage resources and oversee the work of biostatistics and statistical programming staff.

Provide statistical expertise in developing programming standards, procedures, and clinical documents.

Support project management, including oversight, sample size calculations, and statistical consultation.

Job description

Position Summary:
Responsible for leading the biostatistics efforts for specific projects and studies, including reviewing statistical sections of protocols, writing statistical analysis plans, and developing SAS programs. In addition, responsible for managing resources within the Biostatistics and Statistical Programming department. As part of the Biostatistics team, this person will also provide technical expertise to the development of programming standards and procedures.

Essential functions of the job include but are not limited to:

Manage employees, including senior level, within the Biostatistics and Statistical Programming functional areas
Assist with development and maintenance of departmental procedures and standards
Assist with project forecasting and resourcing needs through a combination of internal and external resources
Hire, train, and provide development opportunities for Biostatisticians and Statistical Programmers
Write and/or review statistical analysis plans
Provide sample size calculations
Provide randomization schedules and serve as the unblinded statistician
Program and/or QC CDISC datasets, tables, and figures using SAS
Provide input to and/or QC clinical documents, including CRFs, protocols and CSRs
Provide oversight for assigned projects
Perform the senior level review on a final analysis package delivery of outputs
Provide statistical consultative support
Assist in creation/review of forms and templates
Participate in business development activities
Assist other functional areas as needed

Qualifications:
Minimum Required:

MS degree in statistics, biostatistics, mathematics or equivalent with 6+ years relevant industry experience

Other Required:

Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
Experience with SAS
Familiarity with most complex statistical methods that apply to Phase I-IV clinical trials

Preferred:

Experience with oncology and rare disease
Experience with submissions

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

Competencies:

Sound judgment/decision making
Ability to establish and maintain effective working relationships with coworkers, managers, and clients
Ability to lead and inspire excellence within a team
Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency
Results oriented, accountable, motivated, and flexible

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

$141,200—$211,800 USD

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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 QuestionForHR@precisionmedicinegrp.com.

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