Associate Director, Statistical Programming

bioM?rieux BV; Plymouth Meeting (PA); Hybrid; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a lead statistical programmer to manage and support programming activities for clinical development. In this pivotal role, you will collaborate with cross-functional teams to ensure high-quality deliverables and compliance with regulatory standards. The position requires strong expertise in SAS programming, CDISC standards, and project management skills. You will also mentor junior programmers while driving continuous improvement initiatives. This role offers the opportunity to work in a dynamic environment where your contributions will significantly impact clinical research outcomes. If you are passionate about data and innovation, this position is perfect for you.

Qualifications

• Master's or Bachelor's in Statistics/related field with extensive programming experience.
• Strong project management and communication skills are essential.

Responsibilities

• Lead statistical programming for clinical studies and manage timelines.
• Provide oversight for external vendors and ensure high-quality deliverables.

Skills

Statistical Programming

Project Management

SAS Programming

CDISC SDTM/ADaM Standards

Data Analysis

Communication Skills

Education

Master’s Degree in Statistics or related field

Bachelor’s Degree in Statistics or related field

Tools

SAS

Macros Programming

Job description

Job Description

The Position

Responsibilities

• Support and manage statistical programming activities to all clinical development programs and internal initiatives.

• Act as a lead statistical programmer and project manager for the studies, compound and or one or more therapeutic areas (TAs) and interact with other stakeholders in the team.

• Provide expert-level hands-on support for all internal statistical programming needs including, but not limited to, ISS and ISE summaries and exploratory data analyses.

• Provide oversight and quality control (QC) of external vendors to ensure high-quality deliverables and manage timelines for the outsourced studies. Standardize and work on process improvement and programming within TA and compound and strategize for the long-term seamless management of the program.

• Collaborate with biostatistics, data management and others to provide technical support for ongoing trials, FDA submissions, publications, and other business needs.

• Develop and validate standard department/generic macros and template programs.

• Utilize strong knowledge on CDISC SDTM/ADaM data standards and regulatory requirements.

• Write or review and approve data specifications for SDTM and ADaM.

• Write SAS programs to generate or validate SDTM, ADaM, and TLFs.

• Manage and be willing to coach and mentor junior programmers.

• Participate in the development and implementation of innovative strategies.

• Participate in development, maintenance and adherence to departmental SOPs and Guidelines.

• Lead in continuous improvement initiatives within Biometrics and represent in cross-functional departmental initiatives.

Required Education, Experience and Skills

• Must have a Master’s degree in Statistics, Mathematics, Engineering, Computer Science, or Life Science plus at least nine years of statistical programming experience in a Contract Research Organization (CRO), biotech or pharmaceutical industry OR a Bachelor’s degree in Statistics, Mathematics, Engineering, Computer Science, or Life Science plus at least ten years of statistical programming experience in a Contract Research Organization (CRO), biotech or pharmaceutical industry.

• Experience working for regulatory and publication support requests and working with an outsourced model is also required.

• Advanced working knowledge of CDISC SDTM, ADaM, Define.xml and submission standards; and advanced knowledge of SAS and Macros programming is required.

• Must possess strong project management skills to prioritize tasks, negotiate timelines, and ensure timely deliverables with the highest quality; and excellent written and oral communication skills.

• Ability to manage and work on multiple projects and shifting priorities; and to write generic SAS macros and provide out-of-the-box solutions is required.

Telecommuting permitted. 40 hours per week. Must have proof of legal authority to work in the United States. To apply, create a profile and submit your CV for Job Req. #R533377.