Senior Manager, Statistical Programming

EDETEK; Oregon; Híbrido; USD 120.000 - 170.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Paid time off

401K plan

Dental plan

Vision plan

Employee assistance program

Descripción de la vacante

EDETEK Inc. is seeking a Senior Manager of Statistical Programming who will stay hands-on with daily activities of a Statistical Programmer or Sr. Statistical Programmer.

The role programs CSR tables, listings and graphs, and leads projects while writing Base SAS code with macros in line with the SAP. You will train junior staff, communicate timelines with clients, ensure data integrity, and collaborate with IT and QA on procedures and validation of CONFORM modules.

Formación

• Master's degree or higher in Biostatistics, Computer Science or Mathematics or equivalent.
• At least 2 years of clinical SAS programming experience for the manager position.
• Strong SAS programming language and knowledge of clinical trial data.
• Excellent English communication, both written and verbal.

Responsabilidades

• Program CSR tables, listings and graphs per SAP.
• Act as lead programmer for assigned projects.
• Develop customized data displays using shells/templates.
• Write Base SAS code and macros.
• Prepare documentation for programs and datasets.
• Coordinate with clients to manage timelines and deliverables.
• Train junior team members on regulations and internal tools.
• Collaborate with IT for secure SAS server access.
• Assist QA with SOPs, testing and validation of CONFORM modules.

Conocimientos

SAS programming

English communication

Project management

Team leadership

Data analysis

Attention to detail

Clinical trial knowledge

Educación

Master's degree or above in Biostatistics/Computer Science/Mathematics

Herramientas

Base SAS

SAS macros

SAS procedures

SAS Enterprise Guide

Descripción del empleo

The Senior Manager of Statistical Programming will stay hands-on with daily activities of a Statistical Programmer or Sr. Statistical Programmer.

• Programs all tables, listings and graphs necessary for an assigned clinical study report (CSR);
• Acts as lead programmer for assigned projects;
• Programs customized data displays, (including data listings, summary tables and routine graphics) in accordance with the approved statistical analysis plan (SAP) and shell displays for clinical research studies;
• Writes code using Base SAS programs, SAS procedures, or standardized macros;
• Analyzes protocol, SAP, existing shells/templates as needed to understand structure and content of data;
• Performs data checks as needed, to ensure integrity and correctness of data displays;
• Prepares documentation for programs;
• Prepares documentation describing all datasets and variables within, including derived variables, and the project as a whole;
• Creates SAS datasets of clinical data from clinical databases;
• Creates status and efficacy datasets;
• Creates project-specific macros and formats;
• Loads client data from other platforms and other software packages;
• Prepares data to be sent to clients and as needed for other external transfers and data imports.

• Communicates with clients to set and manage project timelines and deliverables;
• Assigns projects to the team and solves problems and/or technical difficulties;
• Trains junior team members on industry regulations, standards and internal tools used;
• Works with IT department to setup and ensure a secure environment with proper access control on SAS servers;
• Works with Quality Assurance team on Standard Operation Procedures drafting and revision, as well as testing and validation of CONFORM modules.

Requirements

• Ability to communicate effectively in English, in both writing and verbal.
• Ability to learn quickly and pay attention to details.
• Ability to manage multiple tasks/projects, effectively prioritize and execute tasks, and make quality and on time deliveries.
• Ability to work collaboratively, effectively, and productively in diverse organizational structures, and in interaction with dynamic clients.
• Ability to work independently, takes ownership and strives for quality and efficiency.
• Ability to work positively in a continually changing environment.
• Solid/Advanced SAS skills and understanding of the concept of standardization in data, programming, and statistical reporting of trial results and its implication to drug development.
• Master's degree or above in Biostatistics, Computer Science, Mathematics, or a combination of education and relevant industry experience.
• Strong SAS programming language and good knowledge/experiences of clinical trial and drug development.
• At least 2 years of clinical SAS programming experience for the manager position.
• Some travel (5%) may be required with a potential of travel occurring over weekends.

Note on Position Level

We are open to considering qualified candidates at the Senior Manager, Associate Director, Director level, or above, depending on experience and qualifications.

Benefits

BenefitsBenefits vary by country, but remain competitive. Below is a sample of the benefits offered to U.S. employees.

• Choice of comprehensive Medical, Vision and Dental Insurance plans
• Paid vacation time and sick days
• Corporate holidays annually
• Participation in the 401K Plan
• Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc.
• Health Advocate and Employee Assistance Program

Location

This position is open to onsite, hybrid, or remote candidates within the United States.

Equal Opportunity Employer Statement

EDETEK is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual's race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. Whenever possible, the company makes reasonable accommodations for qualified individuals with disabilities to the extent required by law.