Data Science Professional for Regulatory Submission

6 days ago

Marquand, Missouri, United States Eli Lilly Full time

Leverage your passion for data science to drive regulatory submission success at Eli Lilly, a global healthcare leader headquartered in Indianapolis, Indiana. We're seeking a talented professional to join our team as a Data Science Professional for Regulatory Submission.

As a Data Science Professional for Regulatory Submission, you will play a critical role in ensuring the delivery of high-quality submission data to regulatory authorities. Your expertise in data management and analysis will be instrumental in driving the development of submission data deliverables that align with the compound's data strategy.

This role requires a strong foundation in data science, including experience with clinical data management, drug development, and regulatory requirements. You will work closely with cross-functional teams to ensure the development of submission data deliverables that meet the needs of regulatory authorities.

A key aspect of this role is the ability to communicate complex data concepts to both technical and non-technical stakeholders. You will need to possess excellent written and verbal communication skills, as well as the ability to influence and communicate effectively across teams.

The ideal candidate will have a bachelor's degree in a relevant field, such as statistics, mathematics, or computer science. You will also need to possess strong skills in SAS/R programming languages, as well as experience with CDISC format standards and data standards.

This role offers a competitive salary of $120,000 - $150,000 per year, depending on experience, plus additional benefits and a comprehensive compensation package. You will also have the opportunity to work with a talented team of professionals and contribute to the development of innovative solutions that drive regulatory submission success.

Eli Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status. We are committed to creating a diverse and inclusive work environment that values the contributions of all employees.

As a Data Science Professional for Regulatory Submission, you will have the opportunity to work on challenging projects and develop your skills in data science and regulatory submission. You will also have access to ongoing training and development opportunities to ensure your continued growth and success.

Join our team at Eli Lilly and contribute to the development of innovative solutions that drive regulatory submission success. Apply now to become a Data Science Professional for Regulatory Submission and take the first step towards a rewarding and challenging career.

Responsibilities:

  • Develop and implement data management strategies to ensure the delivery of high-quality submission data to regulatory authorities.
  • Work closely with cross-functional teams to ensure the development of submission data deliverables that meet the needs of regulatory authorities.
  • Communicate complex data concepts to both technical and non-technical stakeholders.
  • Influence and communicate effectively across teams to drive regulatory submission success.
  • Develop and maintain effective business partnerships with teams, functions, affiliates, and TPOs.
  • Track and maintain process metrics.
  • Provide root cause analysis as needed for process audits and assessments.
  • Continually seek and implement means of improving processes to reduce cycle time and decrease work effort.
  • Represent SDnA and/or Global PK/PD processes in multi-functional initiatives.
  • Actively engage in shared learning across Statistics, Data, and Analytics.
  • Work with partners to increase vendor/partner efficiencies.
  • Proactively identifies ways to improve day-to-day activities and practices.
  • Support efforts to improve productivity, efficiency, product quality, and reduction of risk.

Basic Qualifications/Requirements:

  • Bachelor's degree in a relevant field, such as statistics, mathematics, or computer science.

Other Information/Additional Preferences:

  • Experience in clinical data management and/or drug development in areas intersecting with clinical data management (e.g. clinical operations, statistics, information technology, health outcomes, pharmacokinetics/pharmacodynamics, etc.) is highly preferred.
  • Demonstrated knowledge of clinical programming processes and technology.
  • Demonstrated ability to understand and apply data flow, data quality, data interchange, data standards, and data representation principles.
  • Solid understanding of global internal, external, and regulatory requirements/expectations (CCS, ICH, GCP, PhRMA, CSUCI, etc.).
  • SAS/R skills and other programming/statistical languages.
  • Knowledge of CDISC format standards (SDTM, ADaM) and data standards.
  • Familiar with PK/PD NONMEM and NCA datasets.
  • Effective written and verbal communication skills in multi-cultural settings.
  • High learning agility, initiative, is flexible and has a positive demeanor.
  • Good interpersonal and leadership skills.
  • Interpersonal/teamwork and communication skills for effective customer consultation.
  • Strong business acumen.
  • Demonstrated strength in logical thought, problem-solving ability, and critical thinking.
  • Demonstrated ability to communicate and influence across SDnA, Global PK/PD, CDDA, TPO's, other functional business partners, and with external industry forums.

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