Principal Biostatistician

Biostatistician

Additionally, you'll be responsible for advising and leading the planning, development, and implementation of industry (CDISC and regulatory) compliant, high-quality clinical data standards, infrastructure, or automation technologies. You will provide expert support and stellar customer focus to business users and teams on their use of various data-related tools and processes.

About the Role: Key Responsibilities

Study Level

• Responsible for all statistical tasks on assigned trials, performing mid- to high-complexity trials independently with peer review/input as required.
• Responsible for

  protocol development

  in alignment with the development plan, developing statistical analysis plans, and reporting activities.
• Contribute to planning and execution of exploratory analyses, PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation.
• Initiate, drive, and implement novel methods and innovative trial designs in alignment with the Lead Statistician.
• Explain statistical methodology and interpret analysis results.
• Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities, and other drug development activities as required.
• Contribute to interactions with external review boards/ethics committees, external consultants, and other external parties with appropriate oversight.
• Represent Novartis in statistical discussions at external congresses, conferences, and scientific meetings.
• Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for assigned trials.
• Responsible for functional alignment and ensuring line function awareness throughout the assigned trials.
• Collaborate with other line functions, explaining statistical concepts clearly to non-statisticians and providing adequate statistical justifications for actions/decisions/statements when required.
• Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team.
• Oversee all Biostatistics resources and deliverables for assigned trials.
• Ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities.

Project Level

• May be a core member of an early project team for a low-complexity program, representing Biostatistics and Pharmacometrics as part of the development plan with oversight.
• Collaborate with clinical, regulatory, and other strategic functions to drive quantitative decision-making in assigned indications/programs with oversight.
• Collaborate cross-functionally (e.g., data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables.
• Propose and implement innovative designs and methods to optimize dose finding and drug development.
• Contribute to planning, prioritization, and tracking of program-level biostatistics activities and effective partnership with vendors.
• Significantly contribute to project team preparation for Health Authority (HA) Advisory Committees and meetings.

Franchise or Global Line Function Level

• Significantly contribute to initiatives at the global line function level.

Enterprise Level

• Actively contribute to cross-functional organizational/process/scientific consulting improvement initiatives.
• Contribute to the review and implementation of health authority guidance.
• Identify, evaluate, and promote the use and acceptance of innovative methods within and outside the organization, through scientific collaborations, publications in scientific peer-reviewed journals, presentations, and chairing sessions at professional meetings.

External Level

• Contribute to interactions with external review boards/ethics committees, external consultants, and other external parties with appropriate oversight.
• Represent Novartis in statistical discussions at external congresses, conferences, and scientific meetings.

Role Requirements

• MS (in Statistics or equivalent) with 7+ years of relevant work experience

  OR

  PhD (in Statistics or equivalent) with 3+ years of relevant work experience

  .

• Fluent English

  (oral and written) with good communication and presentation skills.
• Ability to influence decisions that directly impact the trial/project and team's ability to deliver objectives.
• Experience in all tasks of a statistician at the trial/experiment level and demonstrated independence in the role.
• Proven knowledge and expertise in statistics and its application to clinical trials; able to explain statistical designs and concepts.
• Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modeling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills.
• Proficiency in the use of statistical software packages (e.g.,

  SAS, R

  ).
• Good knowledge of drug development and Health Authority guidelines.
• Demonstrated effectiveness working on a multidisciplinary team to achieve team objectives.
• Good understanding of Franchise/Therapeutic Area and/or regulatory activities.
• Good project management and matrix leadership skills.
• Ability to collaborate well with non-statistical functions.
• Adherence to good business ethics.