Senior Manager, Statistical Programming

Travere Therapeutics; San Diego (CA); In loco; USD 132.000 - 172.000; Tempo pieno

Descrizione del lavoro

Travere Therapeutics in San Diego is seeking a Senior Manager, Statistical Programming to lead programming across clinical programs and ensure timely, high-quality deliverables. You will plan, code, and validate analyses and reports, while guiding CROs and cross-functional teams.

Requirements include 7+ years in clinical research as a SAS programmer, lead programming experience, SDTM/ADaM/Define.XML expertise, and strong communication. On-site with occasional travel; base in San Diego.

Competenze

• Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related technical discipline.
• Master’s degree preferred.
• 7+ years’ experience in clinical research, ideally as a SAS programmer for phase I–IV trials.
• Lead Programmer experience is required.
• Strong knowledge of SDTM, ADaM, Define.XML and regulatory standards.

Mansioni

• Provide programming support across all programs and coordinate with Biometrics teams.
• Lead projects, oversee vendors, and ensure timely, quality programming deliverables.
• Develop/validate SDTM/ADaM datasets, Define.xml, tables, listings, and figures.
• Prepare submission programming deliverables and support regulatory filings.
• Develop SAPs, CRFs, specifications, validation plans, and CSRs; collaborate cross-functionally.

Conoscenze

SAS programming

Lead Programmer

CDISC SDTM/ADaM

Define.XML

Validation

Vendor management

Regulatory submissions

R software

UNIX/Windows

ODS/SQL/MACRO

Formazione

Bachelor’s degree in Statistics, CS, Math, or related field

Master’s degree preferred

Strumenti

SAS

R

MS Office

UNIX

Descrizione del lavoro

Department:106300 BiometricsLocation:San Diego, USA- RemoteBe a part of a global team that is inspired to make a difference in the lives of people living with rare disease.At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because we are making a difference. We are passionate about what we do.We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission – to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients .Position Summary:The Senior Manager, Statistical Programming will work closely with the Associate Director, Statistical Programming and other members of the Biometrics team to provide programming support across all programs. The Senior Manager will independently plan and coordinate assigned programming activities, provide hands-on programming and validation support to project teams, and oversee external vendors to ensure timely and accurate deliverables. This role will also provide technical expertise to development programming standards and procedures and will work cross-functionally.Responsibilities :Provide strategic input regarding the development of statistical programming processes and contribute to maintaining programming-related SOPs, work instructions, and technical standards.Assist in the development of programming standards and tools to improve the efficiency and accuracy required to support the analysis and reporting for clinical development projects.Lead projects/studies, oversee contractors, and ensure quality and timeliness of programming deliverables.Program analysis datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), DSUR, PSUR, IB, progress reports, electronic submissions and other internal and external requests (e.g., publications, responses to regulatory questions).Review/Develop CDISC specifications and review/generate SDTM data sets, ADaM data sets, and Define.xml files along with all supporting documentation for submissions.Provide statistical programming and validation support for clinical study reports, oversee external vendors (e.g., CROs), and coordinate programming activities with Biometrics lead, data managers, and other study programmers.Develop and/or review SAPs, case report forms, clinical DB specifications, validation plans, TLFs, reporting and analysis datasets specifications, and supporting documentation.Provide input on the application of programming methodologies to support the clinical development process.Additional duties assigned as need.Education/Experience Requirements:Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related technical discipline required. Master’s degree preferred. Equivalent combination of education and applicable job experience may be considered.7+ years’ experience in clinical research required, ideally as a SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment. Lead Programmer experience is required.Technical knowledge and experience with SDTM, ADaM, and Define.XML.Additional Skills/Experience:The ideal candidate will embody Travere’s core values: Courage, Community Spirit, Patient Focus and Teamwork.Driven, intelligent, passionate about making a difference for patients with rare diseases.Strong understanding of the drug development process, submission-related activities and regulatory requirements (e.g. CDISC, CDASH, eCTD) and guidelines (eg, ICH, CHMP, FDA, GCP).Experience in managing vendors and/or direct reports.Demonstrated experience preparing and validating technical submission programming deliverables in accordance with applicable standards, procedures, and regulatory requirements.Thorough knowledge of SAS functionalities (including ODS, SQL, MACRO, STAT, GRAPH, and ACCESS) and experience with MS Office are required. Familiarity or experience with R Software is a plus.Proven experience with UNIX and Windows operating systems.Understanding of the software development life cycle.Ability to effectively communicate and perform in a high demand and dynamic working environment.Excellent communication skills and interpersonal skills.Experience in solving complex and increasingly difficult problems by taking appropriate corrective action and implementing improvements.Self-motivated and can independently manage responsibilities with minimal supervision.Demonstrate initiative, sound judgement, and flexibility; possess effective time management and organizational skills; and capable of working on multiple projects simultaneously under tight timelines.Ability to travel 10% domestically and internationally.All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.Total Rewards Offerings :Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.Benefits: Our benefits include premium health, financial, work-life and well-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off.Compensation : Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.Target Base Pay Range:$132,000.00 - $172,000.00*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate’s experience, education, skills, and location.Travere will accept applications on an ongoing basis until a candidate is selected for the position.Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to [e-mail] . Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.