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Director, Regulatory Affairs - CMC

Blue Bell, PA · Remote

$143K - $189K/yr

Director, Regulatory Affairs CMC Location The position may be remote based across the US, or East ... Biosimilars, CGT, ADC & Vaccines), Peptides and Radiopharmaceuticals in particular with CMC ...

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Remote Biosimilars information

What are some common challenges faced when working remotely in biosimilars development, and how can they be addressed?

Remote roles in biosimilars development often involve collaborating with cross-functional teams spread across different locations and time zones, which can make communication and project alignment challenging. To address these issues, professionals typically rely on regular virtual meetings, clear documentation, and project management tools to ensure everyone stays informed and aligned. Additionally, staying up-to-date with regulatory changes in multiple markets can be demanding in a remote setting, so leveraging industry webinars, online resources, and collaborative platforms is essential. Building strong relationships with colleagues and proactively seeking feedback can also help overcome the distance and maintain high productivity.

What are the key skills and qualifications needed to thrive as a Remote Biosimilars Specialist, and why are they important?

To thrive as a Remote Biosimilars Specialist, you need a strong background in pharmaceutical sciences, regulatory knowledge, and experience in biologics or biosimilars, often supported by a relevant degree such as pharmacy, biology, or chemistry. Familiarity with regulatory submission systems, pharmacovigilance databases, and industry-standard software like Veeva Vault or Salesforce is typically required. Excellent communication, analytical thinking, and collaboration skills are crucial for engaging with cross-functional teams and external stakeholders. These skills ensure compliance, effective information sharing, and successful market access in the competitive biosimilars industry.

What are remote biosimilars?

Remote biosimilars typically refer to professionals who work remotely in the field of biosimilars—biological products that are highly similar to approved biologic medicines. These roles can include regulatory affairs, medical writing, sales, pharmacovigilance, or research, all focused on biosimilar products. Working remotely allows experts in biosimilars to collaborate with pharmaceutical companies, research institutions, or regulatory agencies from any location, leveraging digital tools and platforms to advance the development and accessibility of these medicines.
More about Remote Biosimilars jobs
What cities are hiring for Remote Biosimilars jobs? Cities with the most Remote Biosimilars job openings:
What are the most commonly searched types of Biosimilars jobs? The most popular types of Biosimilars jobs are:
What states have the most Remote Biosimilars jobs? States with the most job openings for Remote Biosimilars jobs include:
What job categories do people searching Remote Biosimilars jobs look for? The top searched job categories for Remote Biosimilars jobs are:
Remote Biosimilars jobs near you
Infographic showing various Remote Biosimilars job openings in the United States as of May 2026, with employment types broken down into 100% Full Time. Highlights an 100% Remote job distribution.

Biostatistics Senior Manager, Biosimilars US- Remote

Amgen, Inc.

Remote

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 8 days ago

Job description

Career Category
Medical Affairs
Job Description
Join Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Biostatistics Senior Manager, Biosimilars US- Remote
Let's do this. Let's change the world. In this vital role you will lead a single large product, and/or more complex studies and/or projects, ensures that all statistical aspects of documentation pertaining to clinical activities meet required standards and are statistically correct, influences and contributes to the development strategy, and defends statistical approaches internally and externally.
Responsibilities
  • Implements, oversees and supports standards, technical quality and consistent approaches in strategy, study design and statistical analysis.
  • Plans and executes statistical contributions to 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), and other communications in close partnership with CROs in a full-service CRO model.
  • Provides statistical inputs to clinical publications, Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), and regulatory documents.
  • Oversees statistical work performed by CROs in a full-service CRO model.
  • Performs statistical analysis of multiple studies/projects and subsequent exploratory analyses, and makes sound conclusions and recommendations.
  • Represents the Biostatistics function and participates in multidisciplinary project team meetings; collaborates closely with other functional team members; incorporates knowledge of cross-functional areas to inform and provide sound statistical guidance to teams (e.g. provides support and input in case report form design, and data collection).
  • Proactively anticipates and communicates resource and quality issues that may impact deliverables or timelines within functional area as well as cross-functionally.
  • Be familiar with statistical policy and strategy at Amgen; having working knowledge of theoretical and applied statistics and of regulatory guidelines and industry practice on biosimilar development.
  • Stays abreast of latest developments in the field of statistics in drug development and contributes to scientific advances by publishing applied research in scientific journals and books and presenting statistical methodology at internal or external scientific meetings.
  • Participates in the review of CRO Policies, SOPs and other controlled document development, and in the development and review of Amgen-CRO's process maps; contributes to process improvement and operational efficiency.
  • Adheres to all Amgen Policies, Standard operation procedures (SOPs) and other standards which are applicable to biosimilar development.

What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a Biostatistics Senior Manager, with these qualifications.
Basic Qualifications
  • Doctorate degree and 2 years of Biostatistics experience
    OR
  • Master's degree and 6 years of Biostatistics experience
    OR
  • Bachelor's degree and 8 years of Biostatistics experience

Preferred Qualifications
  • Masters degree in Statistics/Biostatistics or other subject with high statistical content, and 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research

Or
  • Doctoral degree in Statistics/Biostatistics or other subject with high statistical content, and 5 years of post-graduate statistical experience in the pharmaceutical industry or medical research
  • Knowledge/experience of biosimilars development, non-inferiority or equivalence trials
  • Statistical contributions to regulatory submissions
  • Experience in statistical methodologies related to adaptive designs (e.g., group sequential design, adaptations to treatment arm selection design, Bayesian adaptive design) and/or combined phase 1/2 or phase 2/3 design
  • Independent leadership of the design, analysis and reporting of at least 1 complex or multiple less complex studies/projects within the Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia
  • Demonstrated ability to provide sound strategic and statistical input on study/research design to meet project needs, regulatory and scientific requirements
  • Demonstrated ability in presenting results and defending statistical findings, study design and analysis. This could be to internal audiences (study/product team) or at external meetings such as investigator meetings, steering committee meetings, ad board meetings or regulatory meetings
  • Demonstrated ability in working within a global team and with CRO partners to ensure operational excellence and efficiencies
  • Demonstrated effective communication skills (written and oral)

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, we'll support your journey every step of the way.
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.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
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.
Salary Range
154,104.15USD -208,493.85 USD

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