What You Will Do

The position is responsible for:

Leading and supporting all programming activities per the project strategies and should be able to work independently implementing and driving the programming to support clinical studies, regulatory submission and ad hoc/ post hoc analysis.
The incumbent will work closely with biostatistics, data management, clinical research, regulatory affairs, and external functional service providers to ensure all the programming results are delivered in timely manner with high quality.
This role also participates in preparation and improvement of relevant standard operating procedures.
If you re passionate about driving excellence in statistical programming and contributing to clinical development programs, this role provides the perfect platform to make a meaningful impact.

Key Responsibilities

Provides expert support and direction in statistical programming design to ensure timely and accurate reporting for assigned projects and ad hoc requests.
Manage programming activities for clinical studies, including activities related to data management, statistical analysis, and reporting.
Ensure all SAS Programming activities are conducted in accordance with high ethical and quality standards, GCP regulations, and company procedures.
Oversee programming activities to ensure adherence to protocols and statistical analysis plans.
Demonstrate strong problem-solving and debugging skills to address issues with code from other programmers or vendors.
Develop and manage specifications for Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets, as well as data submission package preparation.
Develop, manage, and maintain analysis data and reporting deliverables.
Create global standard macros to enhance the efficiency of the Statistical Programming Group.
Possess a basic understanding of FDA/ICH guidelines, 21 CFR Part 11, and other FDA regulations.
Proactively addresses project uncertainties to minimize risks, escalating issues as necessary to the appropriate stakeholder (project team member, lead biostatistician, or management) and identifying and overcoming technical and interpersonal challenges.
Manage internal resources and external vendors to ensure project success.
Mentors less experienced programmers.
Contribute to the continuous improvement of statistical programming processes and procedures.

What We Are Looking For

Required Qualifications

Bachelor s degree in Statistics, Mathematics, Computer Science, Life Sciences or related field is required. A Master s degree is preferred.
Candidate should have either a Bachelor s degree with 8+ years of statistical programming experience or a Master s degree with 6+ years of relevant experience in Biotech, Pharmaceutical, or health related industry.
Proficiency in SAS Base, STAT, Graph, Macro.
Experience with electronic submissions in the electronic Common Technical Document (eCTD) format is considered a plus.
Experience with Clinical Data Standards Consortium (CDISC) data standards, SDTM and ADaM is required.
Experience supporting an Integrated Summary of Safety (ISS) or Integrated Summary of Efficacy (ISE) is considered a plus.
Excellent oral and written communication skills are necessary, along with strong interpersonal skills.
Excellent problem-solving skills.
Effective collaboration in cross-functional teams both internal and external to the organization.

Principal Statistical Programmer

Job Description

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