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Associate Director Biostatistics

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Novartis

23d ago

  • Job
    Full-time
    Expert Level
  • Data
    Research & Development
  • Dublin

AI generated summary

  • You need an MS in Statistics with 10+ years or a PhD with 6+ years, strong statistical expertise, leadership skills, regulatory experience, and the ability to mentor associates.
  • You will handle statistical tasks for clinical trials, develop protocols and analysis plans, lead innovative analyses, and ensure high-quality deliverables while collaborating across functions.

Requirements

  • MS Statistics with 10+ years’ work experience or PhD (in Statistics or equivalent) with 6years + work experience
  • Fluent in English with strong communication and presentation skills, with the ability to articulate complex concepts to diverse audiences.
  • Effective utilization of innovative statistics and quantitative analytics to influence assigned program team decisions and support department to deliver objectives.
  • Proven knowledge and expertise in statistics and its application to clinical trials. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Demonstrated excellence in use of statistical software packages (e.g. SAS, R). Strong knowledge of drug development and Health Authority guidelines. Experience independently leading a multidisciplinary team to achieve team objectives. Expert skills to facilitate and maximize the contribution of quantitative team. Hands-on experience in leading the interface to regulatory agencies/leading the early clinical development campaign.
  • Experience in providing statistical expertise to support submission activities, including documents, meetings with and responses to Health Authorities, pricing agencies and drug development activities, as required.
  • Strong understanding of Franchise/Therapeutic Area and/or regulatory activities in at least one disease area.
  • Expert scientific leadership skills demonstrated in facilitating and optimizing the clinical development strategy.
  • Strong track record for global scientific leadership in the development and evaluation of modern program/trial design methodologies.
  • Demonstrated strong skills in building partnerships and collaborations. Ability to mentor for up to 8 associates.

Responsibilities

  • Responsible for all statistical tasks on assigned clinical trials, with a high level of independence seeking peer input/review as required. Responsible for protocol development in alignment with the clinical development plan, developing statistical analysis plan, and leading study- and indication-level reporting activities.
  • Contribute to planning and execution of exploratory analyses, innovative analyses related to publications and pricing & reimbursement/submission and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive, and implement novel methods and innovative trial designs and dose-finding strategies in alignment with the Lead Statistician.
  • Independently lead interactions with external review boards/ethics committees, external consultants, and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings.
  • Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the trials.
  • Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications and interpretation of analysis results for actions/decisions/statements, when required.
  • Establish and maintain collaborative relationships and effective communications within the Clinical Trial Team and Biostatistics & Pharmacometrics team.
  • Independent oversight of Biostatistics resources and deliverables for assigned trials.
  • Ensure all Biostatistics deliverables for assigned clinical trials and/or non-clinical related activities are delivered in a timely manner with the highest level of quality.

FAQs

What is the job title for this position?

The job title is Associate Director Biostatistics.

What are the key responsibilities of an Associate Director Biostatistics?

Key responsibilities include overseeing all statistical tasks on assigned clinical trials, developing statistical analysis plans, leading study reporting activities, contributing to exploratory analyses, and ensuring timely delivery of biostatistics deliverables with the highest quality.

What qualifications are required for this role?

Candidates should have a Master's degree in Statistics with 10+ years of work experience or a PhD in Statistics with 6+ years of experience.

Is fluency in any specific language required for this position?

Yes, fluency in English with strong communication and presentation skills is required.

Where is this role located?

The role is based in Dublin, Ireland, in the Novartis Office.

Is this position full-time or part-time?

This position is full-time.

Is there any travel required for this role?

The role may require overseeing interactions with external review boards, consultants, and participation in external congresses and conferences, which may involve some travel.

What are the working conditions for this position?

The role offers hybrid working conditions, requiring 3 days per week or 12 days per month in the Dublin office.

What experience is needed in relation to statistical software?

Candidates should have demonstrated excellence in the use of statistical software packages such as SAS and R.

Does the company have any commitments to diversity and inclusion?

Yes, Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities served.

What kind of team collaboration is expected in this role?

The Associate Director of Biostatistics is expected to establish collaborative relationships and effective communications with the Clinical Trial Team and Biostatistics & Pharmacometrics team, as well as other line functions.

Will there be opportunities for mentoring in this role?

Yes, the role includes the ability to mentor up to 8 associates.

What is the primary purpose of the Development Team at Novartis?

The primary purpose of the Development Team is to reimagine medicine to improve and extend people’s lives.

What types of analyses will the Associate Director Biostatistics be involved in?

The individual will contribute to exploratory analyses, innovative analyses related to publications, pricing and reimbursement, PK/PD analyses, biomarker analyses, and statistical consultations.

What is the significance of the Associate Director Biostatistics in the drug development organization?

The Associate Director plays a critical role in influencing and driving the statistical strategy and innovation, directly participating in cross-functional collaboration and decision-making for clinical development and medical affairs programs.

Does Novartis provide additional resources or support for employee development?

Yes, Novartis offers benefits and rewards to help employees thrive personally and professionally, including career development resources.

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Novartis

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. Around 108,000 people of more than 140 nationalities work at Novartis around the world.

Culture & Values

  • Inspired

    Engage our people. Strive for patients. Live our purpose

  • Curious

    Learn. Be open. Be self-aware

  • Unbossed

    Create clarity. Serve others. Own your actions

  • Integrity

    Be honest. Have courage. Do what’s right