Sr. Principal Statistics Paramus, NJ

ESR Healthcare; Paramus (NJ); On-site; USD 100,000 - 130,000; Full time

Job summary

ESR Healthcare is seeking a Sr. Principal Statistics in Paramus, NJ. This position involves leading statistical activities in clinical trials, ensuring data quality, and providing support for regulatory submissions. Candidates should have a Ph.D. or MS in Statistics or Biostatistics along with significant industry experience and exceptional skills in statistical software, particularly SAS. The role demands excellent communication and organizational skills, along with the ability to work both independently and collaboratively in a fast-paced environment.

Qualifications

• Ph.D. or MS in Statistics or Biostatistics required.
• 4 years (Ph.D.) or 6 years (MS) of experience in the Pharmaceutical/CRO industry.
• Excellent knowledge of SAS and industry standards.

Responsibilities

• Conduct statistical activities for clinical trials and regulatory submissions.
• Design study elements, review databases, and ensure study quality.
• Support statistical analysis and collaborate with cross-functional teams.

Skills

SAS

Statistical analysis

Communication skills

Education

Ph.D. or MS in Statistics or Biostatistics

Job description

Sr. Principal Statistics Paramus, NJ

Experience level:Mid-senior

Experience required:6 Years

Education level:Doctorate

Job function:Management

Industry:Pharmaceuticals

Total position:1

Relocation assistance:No

Visa sponsorship eligibility:No

JOB DESCRIPTION:

• The Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings and marketing.

RESPONSIBILITIES:

• Review protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc.
• Review CRF, database design, and edit check specs
• Review study quality surveillance plan and monitor study conduct
• Prepare and/or review SAP, TFL shells and specifications for variable derivation
• Work closely with Statistical Programmers and Clinical Data Manager in identify data quality issues for key efficacy and safety variables
• Provide statistical and validation support for statistical analysis, analysis datasets and TFL Review study report, manuscripts and other documents related to statistics
• Work on responses to health authorities and execute new analysis required for responses, review statistical inputs for regulatory documents
• Perform other ad-hoc statistical activities as needed
• Works effectively with cross functional groups, study team, and vendors. Proactively control and monitor timelines related to statistics and statistical programming
• Participates in monitoring CRO activities and reviewing CRO deliverables
• Other duties as assigned

QUALIFICATIONS:

• Education: Ph.D. or MS in Statistics or Biostatistics
• Minimum of 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience
• Excellent knowledge of SAS computer package
• Excellent knowledge of industry standards, such as the ICH guidelines, CDISC data structures and FDA guidelines
• Excellent organizational skills, time management, and ability to meet established deadlines.
• Excellent communication and interpersonal skills to effectively interface with others
• Exceptional interpersonal skills and problem-solving capabilities
• Ability to work independently and collaboratively
• Ability to provide leadership for the CRO statisticians and statistical programmers

PHYSICAL AND MENTAL REQUIREMENTS:

• Ability to multitask
• Adapts to change
• Maintain composure under pressure
• Ability to follow verbal or written instructions and use of effective verbal communications
• Adapts change, adjust change and grasps information quickly
• Examine and observe details