Job 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 Master’s 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: