Sr. Principal Statistics

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