Apr 06, 2022

Job Description

1996! In this year Sandoz initiated the world’s first biosimilar development program. Over 20 years of experience in biosimilar development have equipped us with extensive knowledge and outstanding expertise in the development, manufacturing and commercialization of biosimilar medicines to the healthcare community and patients worldwide. This opportunity is waiting for you to contribute to Sandoz success story in the area of biosimilar.

For our team in Holzkirchen (DE) or Princeton (USA) we are looking for a Group Head - Director Biostatistics Biosimilar (d/f/m), working full time (100%) or part time (80%)

Your responsibilities:

• Lead a team of statisticians (3-6 FTEs) within the Sandoz Biosimilar Clinical Development Department
• Be responsible for recruiting and retaining talents, managing performance (including objective setting, review of performance and compensation), and professionally developing and motivating biostatisticians who act as program and trial statisticians
• Lead on priority setting, workload distribution and resource planning, with the aim of ensuring both adequate assignment of resource to projects and balance of workload across the team.
• Be accountable for overall quality and accuracy of the scientific content of materials produced by the team
• Be accountable for sponsor oversight of trial-related activities performed by CROs/external partners
• May serve as deputy for the Development Unit Head for key activities and key meetings
• Act as Program statistician for biosimilar development programs within cross-functional global development teams
• Provide scientific, strategic and statistical input to clinical development strategies and trial designs for biosimilar development programs (including Biomarker, PK, PK/PD and efficacy/safety studies)
• Champion, drive and implement innovative efficient trial designs and novel statistical methods within programs
• Independently lead interactions with Health Authorities (e.g. EMA, FDA, PMDA, NMPA) and key opinion leaders
• Lead planning and execution of innovative statistical analyses and eCTD preparation for regulatory submission and post-marketing activities including publications
• Establish and maintain collaborative working relationships and effective communication within Biostatistics department, Sandoz BCD, Global Program Teams, as well as with Sandoz GMA, Novartis Advanced Methodology and Novartis CD&A
• Explain statistical concepts in an easily understandable way to non-statisticians and provide relevant statistical interpretation and justification of analysis results
• Contribute to Due Diligence assessments for new product candidates
• Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives.
• Represent Sandoz in statistical forums/presentations/discussions at external congresses, conferences or scientific meetings

Diversity & Inclusion / EEO

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

Minimum Requirements

What you’ll bring to the role:
• PhD, PharmD or MS with honors in biometrics, statistics, mathematics, pharmacometrics, clinical pharmacology, or other quantitative discipline preferred
• PhD with 8+ years’ experience preferred OR MS with 12+ years’ experience
• Has advanced knowledge of applying statistics and innovative approaches Expert knowledge in a variety of statistical areas.
• Has advanced knowledge of applying statistics and innovative approaches Expert knowledge in at least 2 of the following key areas in industry and/or academia:
• Design of clinical development programs (including Biomarker, PK, PK/PD and efficacy/safety studies)
• Application of clinical pharmacology and/or pharmacometrics methods
• Bayesian trial design and analysis
• Application of Real World Evidence and machine learning in clinical trials
• Demonstrated Good coaching and mentoring skills
• Good interpersonal and communication skills (verbal and writing) to bridge scientific and business needs, integrating quantitative sciences

Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?

The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.

Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Imagine what you could do at Sandoz!

Commitment to Diversity & Inclusion:
Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
BioPharma SZ
Holzkirchen (near Munich)
Research & Development
Full Time
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Group Head - Director Biostatistics Biosimilar (d/f/m)

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