Senior Scientist, Statistical Programming

MSD•North Wales, PA

1d•$117,000 - $184,200•Hybrid

About The Position

This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. The incumbant is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables. For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle.

Requirements

Bachelor’s degree or equivalent in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field and 5 years of experience in the position offered or a related SAS programming role within a clinical trial environment; or a Master’s degree in these fields and 3 years of experience in the position offered or a related SAS programming role within a clinical trial environment.
Must have 3 years of experience with all the following: SAS and clinical trial programming, including data steps, procedures, SAS/MACRO, and SAS/GRAPH; systems and database.
Designing and developing complex programming algorithms.
Comprehending analysis plans describing methodology to be programmed.
Understanding statistical terminology and concepts; clinical data management concepts; CDISC and ADaM standards.
Ensuring process compliance and deliverable quality.
Designing statistical databases that optimize analysis and reporting.

Responsibilities

Apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.
Support statistical programming activities for late-stage drug/vaccine clinical development projects, including leadership of one or more projects.
Responsible for the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.
Responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.
Act as a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high-quality deliverables.
Provide SAS programming support for Clinical Trials from Phase I through Phase III.
Utilize the CDISC Analysis Data Model (ADaM) dataset specifications and SDTM data to programmatically develop analysis datasets by writing several lines of code in statistical software (e.g. SAS).
Write code for Tables, Listings and Figures (TLFs) macros and implement statistical methodologies.
Generate TLFs as per the SAP by executing analysis dataset programs and TLF macros.
Serve as the Statistical Programming point of contact and knowledge holder through the entire product lifecycle on assigned projects.
Maintain and manage a project plan including resource forecasting.
Coordinate the activities of a global programming team that includes outsource provider staff.
Support NDA/BLA submissions and addressing agency questions as required.
Mentor junior programmers and work with third party vendor programs.