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- Tasks: Lead statistical strategy for clinical trials and collaborate across teams to drive innovation.
- Company: Join Novartis, a leader in reimagining medicine and committed to diversity and inclusion.
- Benefits: Enjoy hybrid work options, competitive rewards, and a supportive community focused on breakthroughs.
- Why this job: Make a real impact on patients' lives while working with passionate professionals in a collaborative environment.
- Qualifications: MS or PhD in Statistics with extensive experience in clinical trials and strong communication skills.
- Other info: Opportunity to mentor associates and represent Novartis at global scientific events.
The predicted salary is between 54000 - 84000 £ per year.
Job Description
This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
Summary We are seeking a highly motivated Associate Director of Biostatistics; you will be required to influence and drive the statistical strategy and innovation through strong collaborations and decision making for assigned trials/programs within (pre/early/full) clinical development and/or medical affairs. Proven experience in supporting complex clinical trials and leading strategy through collaborations with partners across the organization. About the Role
Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives.
To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic areas and platform depth and capabilities – all to bring our medicines to patients even faster.
We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to.
Apply today and welcome to where we thrive together!
The Role:
We are seeking a highly motivated Associate Director of Biostatistics; you will be required to influence and drive the statistical strategy and innovation through strong collaborations and decision making for assigned trials/programs within (pre/early/full) clinical development and/or medical affairs. Proven experience in supporting complex clinical trials and leading strategy through collaborations with partners across the organization.
Representing the Biostatistics and Pharmacometrics function both internally and externally on decision boards, developing and mentoring other statisticians, and providing solutions to the organization. You may have the responsibility of leading a team of up to 8 associates.
This role offers hybrid working, requiring 3 days per week or 12 days per month in our London Office.
Key requirements:
- Responsible for all statistical tasks on assigned clinical or non-clinical trials and perform these tasks for high complexity trials with a high level of independence seeking peer input/review as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, and 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.
- 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.
- Independently lead interactions with external review boards/ethics commit-tees, 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 sound working relationships and effective communication within the clinical trial team and Biostatistics & Pharmacometrics team.
- Independent oversight of 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.
Your Experience:
- 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.
- Strong understanding of Franchise/Therapeutic Area and or regulatory activities. Expert scientific leadership skills demonstrated in facilitating and optimizing the (pre/early/full-) 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 up to 8 associates.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.
Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
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Associate Director Biostatistics employer: Novartis
Contact Detail:
Novartis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director Biostatistics
✨Tip Number 1
Familiarize yourself with the latest trends in biostatistics and clinical trial methodologies. Being able to discuss innovative trial designs or statistical methods during your interview will demonstrate your expertise and passion for the field.
✨Tip Number 2
Network with professionals in the biostatistics community, especially those who have experience at Novartis or similar organizations. Engaging in discussions about their experiences can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to showcase your leadership skills by discussing specific examples where you led a multidisciplinary team or influenced decision-making in clinical trials. This will highlight your ability to drive statistical strategy effectively.
✨Tip Number 4
Stay updated on regulatory guidelines and compliance standards relevant to biostatistics. Being knowledgeable about CDISC and other industry standards will position you as a strong candidate who understands the importance of quality in clinical data.
We think you need these skills to ace Associate Director Biostatistics
Some tips for your application 🫡
Understand the Role: Make sure you thoroughly understand the responsibilities and requirements of the Associate Director Biostatistics position. Tailor your application to highlight your relevant experience in statistical methods, clinical trials, and regulatory submissions.
Highlight Relevant Experience: In your CV and cover letter, emphasize your 10+ years of experience in statistics, particularly in clinical development. Mention specific projects where you led statistical strategy or collaborated with cross-functional teams.
Showcase Communication Skills: Since the role requires explaining complex statistical concepts to non-statisticians, provide examples in your application that demonstrate your strong communication and presentation skills.
Demonstrate Leadership Abilities: Highlight any experience you have in leading multidisciplinary teams and mentoring associates. This will show that you can effectively manage resources and deliverables for assigned trials.
How to prepare for a job interview at Novartis
✨Understand the Role and Responsibilities
Make sure you have a clear understanding of the Associate Director Biostatistics role. Familiarize yourself with the key responsibilities, such as protocol development, statistical analysis plans, and leading study reporting activities. This will help you articulate how your experience aligns with their needs.
✨Showcase Your Statistical Expertise
Prepare to discuss your experience with statistical software like SAS or R, and be ready to provide examples of how you've applied innovative statistical methods in clinical trials. Highlight any specific projects where your statistical insights led to significant outcomes.
✨Demonstrate Leadership and Collaboration Skills
Since this role involves leading multidisciplinary teams, be prepared to share examples of how you've successfully led teams in the past. Discuss your approach to fostering collaboration and how you ensure effective communication among team members.
✨Prepare for Behavioral Questions
Expect questions that assess your problem-solving abilities and how you handle challenges. Use the STAR method (Situation, Task, Action, Result) to structure your responses, focusing on situations relevant to biostatistics and clinical trials.
