Associate Director, Statistical Programming

Rho Inc

131d • $160,000 - $190,000

About The Position

Join us in redefining what it means to work for a CRO. When you work at Rho, it’s more than just a job—you become part of the Rho Factor. We’re a proud bunch of science nerds who love tackling big challenges together. We’re not your typical CRO, and we’re not trying to be. Here, curiosity is encouraged, fresh approaches are welcome, and collaboration is at the heart of everything we do. Whether you’re a data wizard, analytical genius, project mastermind, or any other role, you’ll fit right into the equation of the Rho Factor. Expect plenty of geeky jokes, eccentric personalities, spontaneous brainstorms, and a supportive community where people genuinely care about their work—and each other. You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career. Rho is currently hiring an experienced Associate Director of Statistical Programmer to join our team. In this role, you will be responsible for oversight and management of Statistical Programmers and activities within Rho’s Regulatory Strategy and Biometrics Team.

Requirements

• BA/BS in computer science, statistics, or related field.
• At least 8 years performing statistical programming in the SAS language within the CRO/Pharmaceutical industry.
• Extensive experience as a lead programmer on complex programs, studies, and deliverables.
• Understanding of clinical trials including knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• A minimum of 2 years of experience training, mentoring, and providing feedback for peers and junior level programmers with proven leadership abilities.
• Extensive experience with SDTM model, including transforming raw data files while adhering to CDISC standards as well as SDTM submission deliverables.
• Strong SAS/Base knowledge with an emphasis on data step programming.
• Experience with single study as well as ISS/ISE, DMC, and other adhoc programming.
• Experience providing technical guidance to programming staff and vendors around standards, practices, and specifications.
• Strong data analysis skills.
• Proven ability to develop, troubleshoot, and maintain complex programs and utilities used in design, creation, and validation of CDISC data, study TLFs, and ISS/ISE deliverables.
• Ability to identify challenges, inefficiencies or downstream impacts as well as potential solutions and engagement of appropriate stakeholders to minimize risk and maximize quality for all points of involvement in study planning and execution.
• Ability to provide both support and leadership to multiple projects across a variety of therapeutic areas with no oversight.
• Excellent written, verbal, and interpersonal communication skills and the ability to interact effectively with all levels both within and outside the company.
• Ability to handle multiple projects and priorities with exceptional organizational and time management skills.
• Experience interacting with sponsors is required.

Nice To Haves

• Understanding of ADaM model and experience with specification, programming, and conformance of ADaM CDISC and ADaM submission deliverables is a plus.

Responsibilities

• Ensure that the Statistical Programming team meets timelines, provides high-quality validated deliverables, complies with contractual project requirements within budget, and follows SOPs.
• Provide high-level oversight of complex statistical programming deliverables created by a team and participate in the development of those deliverables as a lead statistical programmer.
• Monitor project status, budget, and resources and communicate with other functional area team members.
• Offer expertise relevant to statistical programming and CDASH data collection for study start up, execution, and close out.
• Serve as key contributor in the development of Statistical Programming strategies, standards, and processes improvement.
• Effectively manage changes to programming activities and study resources due to protocol amendments and changes to overall clinical development programs.
• Act as the external facing primary functional area lead or lead oversight in communications with sponsors, potential sponsors, and vendors.
• Work cooperatively with other internal functional area management representatives to establish and maintain Standard Operating Procedures (SOPs) and guidelines.
• Make recommendations for, and participate actively in, hiring, onboarding, managing and resourcing staff, as well as appraising staff performance and offering input on professional development.
• Evaluate existing and new regulations and global guidelines as well as industry trends relevant to data standards and statistical programming.
• Provide guidance for the statistical programming department, biometrics, and the larger organization on operational goals and technical knowledge.
• Support the assignment of programmers to projects in a manner which keeps them at their utilization goal and which matches them to projects appropriate for their skills, training, experience, and development.
• Meet with department director regularly to evaluate and develop solutions for project resourcing, quality considerations, timelines, budgets, processes, and training needs.
• Support business development activities by contributing to proposals, client presentations, and providing time and cost estimates for statistical programming activities.
• Represent Statistical Programming at internal project team meetings, client meetings, and audits.

Benefits

• Comprehensive benefits package including medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k).
• Paid time off, holidays, parental leave and bereavement leave.
• Encouragement of work-life balance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 501-1,000 employees