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Fda Openings Jobs in Silver Spring, MD (NOW HIRING)

Digital Infuzion

Internship Opportunities

Rockville, MD · On-site

... NIH, FDA, and other federal health agencies. This program is built for candidates who want ... Digital Infuzion Core Values Our team thrives in a creative, open, and growth-oriented environment ...

Smithers

Associate Research Scientist

Gaithersburg, MD · On-site

$75K - $100K/yr

... of the FDA regulated drug approval process. Our expert scientists perform large molecule ... Must be solution oriented and open to input * Must be able to comfortably and successfully operate ...

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What are the key skills and qualifications needed to thrive in FDA job openings, and why are they important?

To thrive in FDA job openings, candidates typically need a strong background in science, regulatory affairs, and analytical skills, often with a relevant degree in biology, chemistry, pharmacy, or related fields. Familiarity with regulatory databases, submission systems (such as eCTD), and certifications like RAC (Regulatory Affairs Certification) are highly valued. Attention to detail, effective communication, and the ability to work collaboratively are essential soft skills for success. These competencies ensure regulatory compliance, thorough review of submissions, and effective teamwork in safeguarding public health.

What are some common challenges faced by professionals starting in FDA roles, and how can applicants prepare for them?

Professionals beginning their careers at the FDA often encounter challenges such as adapting to complex regulatory frameworks, working with cross-disciplinary teams, and managing the pace of policy changes. To prepare, applicants should familiarize themselves with FDA guidelines and regulatory processes, develop strong communication skills to collaborate effectively with scientists, regulators, and industry representatives, and stay updated on current public health issues. Proactive learning and seeking mentorship within the organization can also ease the transition and foster professional growth.

What are FDA openings?

FDA openings refer to job opportunities or vacancies at the U.S. Food and Drug Administration (FDA). The FDA is a federal agency responsible for protecting public health by regulating food, drugs, medical devices, and other related products. These openings span a wide range of roles, including scientists, inspectors, analysts, administrative professionals, and more. Candidates can find current job listings and application instructions on the official USAJOBS website and the FDA’s careers page. Working at the FDA offers the chance to contribute to public health and safety at a national level.
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Associate Director Biostatistics (Oncology)

BioNTech SE

Gaithersburg, MD • On-site

$146K - $234K/yr

Full-time

Posted 22 days ago

Job description

Mainz, Germany; Cambridge, US; Gaithersburg, US; London, United Kingdom; Munich, Germany; New Jersey, US   |   full time   |   Job ID: 11339 

About the role:


As Associate Director Statistical Programming you will be responsible for representing Statistics in all assigned cross-functional clinical study teams and other projects and holding accountability for all statistical aspects, as well as for providing statistical input into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables.


Your main responsibilities are:

  • Work as part of a collaborative, cross-functional team with members from other discipline
  • Perform and/or verify sample size calculations
  • Lead development of statistical analysis plans and TLFs, perform statistical analyses and validate analysis results
  • Participate in planning for health authority meetings, development of associated documents, and the preparation of associated responses
  • Oversee outsourced statistical CRO activities and deliverables ensuring highest quality and in a timely manner
  • Support and participate in the development of departmental strategies
  • Provide guidance to Statistical Programmers on SDTM/ADaM and TLFs specifications development and programming
  • Provide input to database requirements and work closely with Clinical Data Manager to ensure data quality standards are met


What you have to offer:

  • PhD or Masters in (Bio)Statistics, Mathematics or equivalent
  • Minimum 5 years (8 years for masters) in the pharmaceutical industry and/or CRO
  • At least 3 years of work/leadership experience, overseeing statistics staff (internal as well as outsourced) and in representing Biostatistics in a matrix organization and in a multidisciplinary team
  • Experiences in planning, conducting and analyses of oncology or infectious diseases trials from phase I-IV, including scientific publications
  • Experience in answering health authority questions (FDA, EMA) and in leadings statistics on regulatory submissions, including developing ISE/ISS packages
  • Good knowledge and experience of clinical development, study designs, advanced statistical methods (adaptive design and/or Bayesian is a Plus), regulatory guidelines (ICH, FDA, EMA)
  • Good knowledge of statistical analysis software (SAS or R) and sample size calculation software (e.g., EAST and/or NQuery)
  • Very good understanding of special topics like Diagnostics, Biomarker, PK/PD, PRO, RWE, is a plus
  • Very Good analytical skills and bility to analyze complex issues to develop relevant and realistic plans, programs, recommendations, risk mitigation strategies, and the ability to communicate them to cross functional colleagues
  • Strong drive for achieving high quality working results in a timely manner, while always safeguarding ethical standards in work and behaviors
  • Very good communication skills:
    • the ability to express complex analysis in clear language
    • an excellent command of English written spoken

Your remuneration:

If the position is filled in the US, the Expected Pay Range is $146,300/year to $234,100/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities. 
Compensation at other locations may vary significantly.

Inspired? Join our team of pioneers and bright, open minds. From our founders to our scientists to our business professionals, we think out-the-box, believe in ourselves, work agile and stand accountable.

Together, we usher in a new era of immunotherapies and work on realizing our vision.

Do you have any questions?

Please contact Nicole Starak (Talent Acquisition) or jobs@biontech.de with reference to the job ID.

BioNTech, our story.

At BioNTech, we are more than just a biotechnology company - we are a community of innovators, scientists, and leaders dedicated to

revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide,

especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encouragecreativity, and develop

business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and

become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality,

ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status.

We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important - it's a match!

Apply