Lead / Principal Statistical Programmer

We Are Hiring!

Lead/Principal Statistical Programmer

Experience: 8 years

Work location: Remote

Mandatory Skill: SDTM Adam TLF, Efficacy, Oncology and Study Lead

Min 2 yrs in Study lead

Primary Responsibilities

Communicates effectively with Inference project and functional leadership concerning project issues (e.g. data, technical, timelines)

Understand the client requirement and implement it in the project team

Ensures alignment with Heads of US and India Operations about priorities and scope of work assignments. Proactively informs Heads of US and India Operations of issues/risks to the project and potential remediations.

Act as the study lead in unit-based projects. Study planning and execution for quality of the deliverables and timelines.

Provides comprehensive programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis.

Drives the development and implementation of innovative strategies and technologies to improve programming efficiency.

Supports the development of unambiguous and robust programming specifications for programming work.

Identifies opportunities for increased efficiency and consistency within Inference. Contributes to globalization, improvement and standardization of processes, standards and tools.

Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications (SDTM and ADaM), annotated CRFs, and SAS datasets and provide required programming guidance.

Direct the programming activities and monitors progress on programming deliverables.

Contributes to the mentoring of programmers by reviewing work and providing feedback or guiding new associates in process.

Developing training courses, presenting training materials and conducting training as per the teams requirements.

Ability to handle cross function communication with clinical team, data mangers and statistician

Ensure adherence to compliance of standard operating procedures (SOPs) as defined in Quality Management System.

Monitoring team performance and providing timely feedback through formal forum of appraisals

Contributes to the technical evaluation of candidates and supports their successful integration into the organization.

Qualification

Significant knowledge of SAS software (i.e. Base, Stat, Graph components) and general computing as relates to clinical drug development.

Master's degree and certification from SAS. Knowledge of other software (e.g. R) desired.

At least 8+ years of experience as a Senior/Lead statistical programmer in a clinical industry

Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements

Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals

Ability to be flexible and adapt quickly to the changing needs of the organization

Ability to organize multiple work assignments and establish priorities

Excellent verbal and written communications skills

• Ability to manage and mentor team technically

Interested please share your updated resume