Associate Director, Biostatistics
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Job Location:
Monthly Salary:
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .
As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Data Analytics & Computational SciencesJob Sub Function:
BiostatisticsJob Category:
Scientific/TechnologyAll Job Posting Locations:
Allschwil Basel-Country Switzerland Beerse Antwerp Belgium Titusville New Jersey United States of AmericaJob Description:
The Sr Principle Scientist Biostatistics provides lead support for the design execution analysis interpretation and reporting or communication of data evidence for projects within the PALM organisation with minimal supervision. This position takes a leadership role in providing input to program plans and supports statistical aspects of business-critical and/or regulatory questions or commitments and identifies and assists in the implementation of innovative statistical approaches.
This position represents Statistics & Decision Sciences (SDS) in cross-functional and intra-departmental teams or working groups including J&J senior management-level reviews. He/She abides by the Credo and practices J&J Leadership Imperatives for Individuals: Lead Shape Connect and Deliver.
Expertise: Has an established track record of problem-solving and troubleshooting including significant regulatory and decision-making support at a program level. Demonstrates advanced data analytic expertise based on a foundation of statistical principles and a strong track record of applied experience leading to successful support of multiple programs. Is effective in the use of relevant computational tools for study experiment or trial research objectives. Applies advanced statistical methodology in assigned projects such as clinical trials with demonstrated integrated disease/scientific/functional area understanding and health authority acceptability.
Quality and Compliance: Complies with organization and company standard operating procedures in a timely fashion such as training and project time accounting. Understands and aligns with relevant regulatory guidance. Takes responsibility for the quality and timeliness of project deliverables as assessed by stakeholders such as the project team the clinical trial team and the Statistics Area Head. Follows best practices for Data Integrity.
Drug Development: Demonstrates thorough knowledge of pharmaceutical research and development strategies and execution. Is an established leader for providing SDS support to experimental design modeling analysis planning analysis execution interpretation use of RWE when applicable and statistical communications. Is accountable as a point of contact leader for a specific project or program (e.g. CTSL Indication Lead) and the management of all related project/program deliverables. Is an established leader for providing input to team in terms of optimizing study or trial designs in line with study or indication level objectives and supports the team in answering the questions for Regulatory authorities in an optimal way.
Disease Area Knowledge: Demonstrates knowledge across multiple disease areas/targets within or across Therapeutic Areas (TAs).
Innovation: Seen as a recognized leader in an area of technical expertise. Has a track record for suggesting evaluating and implementing successful alternative or innovative approaches to statistical methods or business processes.
Representation: Represents Statistics & Decision Sciences for cross-functional and intra-departmental teams or working groups relating to scientific or process initiatives.
Collaboration: Builds cross-functional partnerships with internal colleagues and with external partners (e.g. Contract Research Organizations (CROs) consultants) to achieve results for project specific needs with focus on improving communication efficiency and productivity. Works cross-functionally to identify and resolve issues.
Complexity: Successfully works on complex programs in terms of Scientific Statistical Health Authority Operational and/or Partnership issues. Identifies and implements advanced statistical approaches to handle complex project/program related features.
Communication: Has very good written oral and interpersonal communication skills. Demonstrated ability to collaborate and consult with non-statisticians translating complex statistical concepts to drug research & development partners. Bridges scientific and business needs integrating quantitative sciences and strong disease or functional area knowledge and appropriate market/competitive intelligence.
Programming: Demonstrates full proficiency in SAS or R as well as a working knowledge of other relevant computational tools as required.
Education and Experience Requirements
- Ph.D. in Statistics or related field with minimum 6 years relevant experience or Masters in Statistics or related field with commensurate years of relevant experience (ideally in late development or MAF).
- Proficient in SAS or R programming.
- Excellent written oral and interpersonal communication skills.
- Ability to work independently.
- Demonstrated ability to work in interdisciplinary contexts outside statistics.
- Have a good understanding of drug development processes and health authority acceptability a proven track record of scientific achievement and project influence including decision-making support at program level.
- Desire to build relationships with various stakeholders promote positive change and the ability to adapt to rapidly changing organizational & business environment. Promote a culture of diversity equity and inclusion within the teams.
Required Skills:
Preferred Skills:
Advanced Analytics Biostatistics Clinical Data Management Clinical Trial Protocols Collaborating Compliance Management Data Privacy Standards Good Clinical Practice (GCP) Proactive Behavior Program Management Quality Assurance (QA) Regulatory Affairs Management Representing Standard Operating Procedure (SOP) Statistical Analysis Systems (SAS) Programming Tactical Planning Technical CredibilityRequired Experience:
Director
Key Skills
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
