Sr Programming Manager

Southern, NJ - Pharmaceutical & Biotech - Remote - Full time

Date Posted: 3/7/2024

Senior Programming Manager
Salary: $130-155K base+15% bonus, 15% stock
Southern, NJ (Remote)

The Senior Programming Manager will be in the Statistical Programming team and Clinical Operations organization, responsible for supporting the development of new therapies by performing programming tasks and leading a small team to complete programming activities within a clinical trial. You will be responsible for ensuring integrity, consistency, and adherence to standards, and ensuring well-structured, high quality data summaries for internal decision making and reporting to health authorities. You will report to the Director, Programming, and work closely with Data Management, Clinical Programming, Statistics, Medical Writing, and other functions, as necessary.

Responsibilities:
Leads programming activities while providing hands-on support. Reviews CRFs for adequacy and consistency. Supports the establishment and maintenance of SDTM and ADaM database standards. Co-develops analysis related derivation rules, develops data specifications for individual trials and provides guidance to internal programmers or vendors for doing the same. Performs database consistency checks on databases delivered by the vendor. Performs sponsor oversight of programming activities performed by vendor. Supports in-house production of tables, figures, and listings by writing programming code following good programming practices. Supports in-house QC process by applying the appropriate measures (writing of code, review of code/deliverable). Supports submissions by ensuring programming deliverables are consistent with current agency standards and guidelines. Supports resource planning and outsourcing of programming activities. Supports developing and reviewing standard processes and templates. Leads process improvements within the programming department. Contributes to ongoing improvements in cross-functional and global collaboration and sharing of better practices and knowledge. Maintains up-to-date knowledge and competencies within relevant therapeutic and professional areas. Maintains up-to-date knowledge on relevant regulatory guidelines / requirements. Proactively develops and maintains good working relationship with stakeholders and colleagues. Participates and represents programming function in teams and meetings. Develops, maintains, and ensures proper documentation is available and properly stored (e.g., in eTMF) for programming activities. Supports development of Dashboards by providing guidance on data structure, organization, and contents of the SDTM-databases to the Dashboard- developers and programmers.

Requirements:
Completed Bachelor’s Degree required or equivalent qualifications (e.g., programming experience and skills in the pharmaceutical industry). At least 6 years of direct experience in programming in the pharmaceutical industry. Knowledge, experience, and technical proficiency in the SAS software package. Experience working in a global context. Proficient in both written and spoken English. Oncology and regulatory submission experience a plus.

As Senior Programming Manager - Acts as a role model. Proactively engages in department activities. Shares learnings with others. Leads and/or contributes to various initiatives within the department. Proactively contributes to support a global organization.

Required competences and skills:
SAS programming. Analytical and problem-solving skills. Knowledge of the CDISC, SDTM and ADaM data models: the corresponding structures and organizations of the data. Contextual understanding of the data. Writes efficient, easily maintained and well documented computer programs. Is systematic and organized in writing and archiving computer programs as well as other documentation.

Please contact Darren Gutowski at dgutowski@clarkdavis.com


$130-155K base+15% bonus, 15% stock

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