Associate Director, Statistical Programming

The Company :

With deep expertise in chemistry Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company bringing together experienced scientists and industry veterans with a proven track record in drug discovery oncology drug development and company building.

The Role :

Reporting to the Senior Director Statistical Programming the Associate Director Statistical Programming will be responsible for implementing statistical analyses using SAS and performing quality review of SAS programs and deliverables for in-house analyses as well as out-sourced programming deliverables. This individual will also perform programming analyses to generate ad-hoc requests for publications and presentations.

This is a remote position that will work closely with Biostatistics Data Management Clinical Operations Regulatory Global Pharmacovigilance and other related disciplines as well as CROs.

Responsibilities :

• Function as lead programmer to produce and / or validate tables listings figures and analysis datasets in response to regulatory requests publication requests and ad-hoc analyses; write specifications to describe programming needs.
• Develop / review TFL shells SDTM and ADaM specifications in collaboration with biostatisticians and other clinical development colleagues.
• Work closely with Data Management and Biostatistics to ensure final databases analyses and reports are accurate.
• Partner with or oversee CROs or Programming vendors to perform the tasks described above.
• Ensure the proper collection management and documentation of clinical trial data according to regulatory requirements.
• Manages project timelines and schedules of specific phases of projects and collaborates with internal personnel and outside customer representatives.
• Identify problems and develop global tools that increase the efficiency and capacity of the Statistical Programming group (e.g. macros or graphical user interface applications).

Competencies Include :

Qualifications :

Annual Salary Range

$180000

$210000

USD

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Required Experience :

Director

Key Skills

Program assessment,FDA Regulations,Manufacturing & Controls,Program Evaluation,budget forecast,Research Experience,Operations Management,Research & Development,Strategic Planning,Contract Management,Leadership Experience,negotiation

Employment Type : Full Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 180000 - 210000