Senior Manager, Statistical Programming

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborate effectively with Clinical Development personnel to achieve project milestones and timelines for statistical data analysis and reporting.

• Act as the project leader.

• Produce or supervise programming outputs, including tables and listings, for study documentation and integrated summaries.

• Engage with Biometrics, Clinical Data Science, Clinical Development, and Regulatory Affairs teams.

• Anticipate resource requirements and coordinate with management and HR for long-term resource allocation within a therapeutic project.

• Update functional management on programming resources needed for projects.

• Oversee a small team of programmers, including full-time employees and contractors.

• Design and/or code analysis files.

• Ensure that programming and documentation adhere to departmental protocols.

• Manage programming activities within a therapeutic project or equivalent.

• Provide both primary and secondary programming support as necessary.

• Execute strategic initiatives.

• Define and generate user-defined statistical reports and ad hoc requests.

• Address study-related issues and conflicts within a therapeutic project.

• Negotiate timelines and foster buy-in and support.

• Directly oversee personnel and manage task performance as needed.

• Participate in cross-functional meetings as a representative of Programming.

• Represent the Company on contracts when appropriate.

• Recommend and facilitate training.

• Foster inclusion, develop talent, and empower teams in the role of a people leader.

⛳️ Requirements

• A minimum of 8 years of experience with a BS degree in Biostatistics/Computer Science or a related field.

• At least 6 years of experience with an MS degree in Biostatistics/Computer Science or a related field.

• No prior experience required with a PhD degree in Biostatistics/Computer Science or a related field.

• An advanced degree in Biostatistics/Computer Science or a related field is preferred.

• More than 8 years of experience in the pharmaceutical/CRO industry is preferred.

• Previous experience in oncology, hematology, or cell therapy is strongly preferred.

• Practical experience in pivotal studies and/or regulatory submissions, such as NDA, BLA, and MAA.

• Comprehensive understanding of clinical programming and/or statistical programming processes and standards.

• Profound knowledge of regulatory requirements concerning statistical programming, including GCP and ICH guidelines.

• Extensive experience in statistical programming using SAS, including the development and application of SAS Macros.

• Advanced understanding of CDISC standards, including CDASH, SDTM, and ADaM.

• Demonstrated experience in leading programming activities.

• Exceptional verbal and written communication, interpersonal, problem-solving, and analytical abilities.

• Thorough knowledge of clinical trial design and reporting processes, regulatory reporting requirements, and electronic data submissions.

• Capability to collaborate with others to define and generate user-defined statistical reports.

• Ability to address study-related issues and conflicts effectively.

• Skills in negotiating timelines and generating buy-in and support.

• Competency to directly supervise personnel; performance or task management may be necessary.

🏝️ Benefits

• Eligibility for discretionary annual bonuses.

• Potential eligibility for discretionary stock-based long-term incentives, which may vary by role.

• Paid time off.

• Company-sponsored medical insurance.

• Company-sponsored dental insurance.

• Company-sponsored vision insurance.

• Company-sponsored life insurance.

• Comprehensive benefits package.