Biostatistics Mgr

Initial Therapeutics, Inc.; United States; On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Comprehensive employee benefits package

Flexible work models

Stock-based long-term incentives

Job summary

Initial Therapeutics, Inc. is seeking a Biostatistics Manager to lead sophisticated studies in General Medicine therapeutic areas. In this role, you will ensure that statistical aspects of clinical activities are robust and valid while influencing strategic developments.

The ideal candidate will have significant experience in statistics or biostatistics, holding at least a Masters degree with 3 years of experience, or a Doctorate degree. We offer a stimulating work environment with a strong focus on professional growth.

Qualifications

• Experience in biostatistics or statistics in clinical or biopharmaceutical settings.
• Familiarity with statistical policy and strategy.
• Proficiency in publishing applied research.

Responsibilities

• Lead sophisticated studies ensuring robust statistical activities.
• Contribute to strategy development and statistical training.
• Assist in audits conducted by external bodies.

Skills

Advanced R programming

Statistical review

Quality control of protocols

Statistical analysis

Education

Doctorate degree in statistics or biostatistics

Masters degree with 3 years of experience

Bachelors degree with 5 years of experience

Job description

Biostatistics Manager

What you will do

Lets do this. Lets change the world. In this vital role you will achieve results through detailed goal setting, accountability measures, effective partnership, performance management, collaboration with other groups and a dedication to serving customers, both inside and outside of, CfDA (Center for Design & Analysis). The Biostatistics Manager independently leads sophisticated studies in the General Medicine therapeutic areas (Cardiometabolic, Inflammation, Nephrology, and Neuroscience), ensuring that the statistical aspects of clinical activities meet required standards and are robust and valid. Will also influence and supply to strategy development, defend statistical approaches and represent GBS (Global Biostatical Science) through participating in and collaborating with multidisciplinary study teams.

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The professional we seek is proficient with these qualifications.

Key activities include:

• Providing statistical contributions, statistical review, and quality control of Key Design Elements (KDE) protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), clinical publications, and other communications
• Completing statistical analysis of individual studies/projects, proficient in advanced R programming
• Publishing applied research in scientific journals and books, and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings (biopharmaceutical industry and academic meetings)
• Being familiar with statistical policy and strategy at Amgen
• Staying abreast of the latest developments in the field of statistics in drug development and contribute to scientific advances in the field
• Communicating the role of the Global Biostatistics department, and may contribute to statistical training within Global Biostatistics and within Amgen
• Assisting in the review of Amgen Policies, SOPs, and other controlled documents
• Assisting with study and systems audits conducted by Amgen CQA and external bodies
• Serving as team member of change / process improvement initiatives

Basic Qualifications:

• Doctorate degree OR
• Masters degree and 3 years of Statistics/Biostatistics experience OR
• Bachelors degree and 5 years of Statistics/Biostatistics experience.

Preferred Qualifications:

• Doctorate degree in statistics or biostatistics

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

Benefits

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan
• Stock‑based long‑term incentives
• Award‑winning time‑off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Equal Opportunity Employer

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.