Manager Statistical Programmer

Location
Working from Home
Posted
May 09, 2022
Ref
REGEA0026R8962
Required Education
Bachelors Degree
Position Type
Full time

The Manager of Statistical Programming provides timely support to the study team on all programming matters according to the project strategies. As an integral part of a study team, the incumbent provides project leadership and programming support for processing data from clinical studies. Requirements will be identified according to a Statistical Analysis Plan, programming specification or user requirements document using internal standards and guidelines. This role also provides guidance in implementing and carrying out the programming and project standards. The incumbent will be responsible for leading the programming aspect of a project, both internally or CROs, for all programming deliverables from the single study through to regulatory approval, product launch, data monitoring boards and annual reports. The manager also supervises documentation and ensures consistent maintenance of code, logs, and output within a regulated environment.

In this role, a typical day may include:
  • Developing an expertise within a therapeutic area or standard tool.
  • Working with minimal supervision to perform, coordinate and oversee the preparation, execution, reporting and documentation of a project.
  • Function as a lead programmer in the development and QC of tables, listings, graphs, or systems in support of analysis requirements using Regeneron tools and methodologies and current industry standards (i.e. CDISC SDTM / ADaM)
  • Managing the effort, including e-submission deliverables, using appropriate tools to track, allocate and summarize extent of work required, progress and completion of programming goals.
  • Providing programming support for complex presentations and more complex statistical ad-hoc requests.
  • If applicable, leading an application development and acting as the programming representative to the user audience.
  • Working with management to determine resource requirements for therapeutic area or department function responsibilities.
  • Reviewing and selecting resumes, screening and interviewing talent for contractor and permanent positions.
  • Providing input to management regarding team member’s contributions to the work effort for evaluating individual's performance and recommend yearly goals.

This role may be for you if:

You can work independently, exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks.

You have advanced SAS programming skills, preferably in a clinical data environment.

You have experience in the analysis of at least one therapeutic area.

You have strong understanding of relational databases and experience working with sophisticated data systems.

You understand reporting systems using multiple data delivery applications.

You have been accountable for development and implementation of standardization methodology.

You are collaborative teammate with interpersonal skills that demonstrate initiative and motivation.

You have excellent verbal and written communication skills in a global environment.

You have experience in pharmaceutical clinical development (i.e. understanding of statistical concepts, techniques and clinical trial principles within a therapeutic area) and ability to provide programming support needs for BLA and other regulatory submissions.

You have shown experience in project management with minimum supervision, including the ability to effectively coordinate and balance multiple assignments with ambitious timelines across multiple personnel.

You have experience in project start-up through submission.

You have proven success hiring, development, evaluation and support of junior staff and contractors.

You have knowledge in creation of current CDISC data structures.

To be considered, you'll need a BS in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field with at least 5 years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry. An advanced degree is preferred. Experience in project and/or people management experience is necessary. SAS, (Base, Stat, Macro, graph) and S-Plus/R. SAS Certification desirable.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.