Manager, Statistical Programming

The Company

This publicly held clinical-stage biotechnology company is focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Their lead product candidate, nomlabofusp, is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich’s ataxia. Friedreich’s ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality.

The company has between 60 and 70 employees and has assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience. The management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, commercialization, and the development of manufacturing processes utilizing good manufacturing practices (GMPs).

The company’s strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team’s know-how and expertise to the development of CTI-1601 and other future pipeline programs. They are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success.

Role and Responsibility

The Manager, Statistical Programming, will support all programming activities for ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis. The role collaborates with internal partnering functions and external functional service providers to ensure all the programming results are delivered in a timely manner with high quality.

• Attend and contribute to internal and vendor study team meetings, working closely with study personnel.
• Review study documents as required.
• Review CRO dataset specifications for conformance to SAPs and CDISC standards.
• Program and QC datasets and TFLs following specifications and good programming practice.
• Perform and document oversight of outsourced activities including Quality Assurance (QA).
• Work closely with Data Management and Biostatistics to ensure final databases, analyses, and reports are accurate.
• Manage expectations and issue resolution.
• Review and input into submission documentation, including SDTM and ADaM clinical data packages.
• Maintain study TMFs.
• Develop and annotate TFL mock shells.
• Provides leadership/expertise for day-to-day statistical programming tasks in support of ongoing projects.
• Manages study timelines and schedules of specific phases of studies and collaborates with internal personnel and CROs.
• Contributes technical expertise to develop global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications).

• BSc or BA in Mathematics, Statistics, Computer Science, or related analytical field
• 5 years statistical programming in a clinical trial setting (industry/CRO) is required.
• Thorough understanding of data standards conformance and compliance
• Advanced SAS programming skills commonly used in clinical trials reporting, including macros, and generating TFLs
• In-depth understanding of CDISC standards including SDTM and ADaM models and extensive hands-on experience of their implementation from raw data in clinical trials.
• Experience with outsourcing programming activities and overseeing services provided by CROs and contractors.
• Skilled at performing quality control checks / validation of SAS code and outputs produced by other Statistical Programmers.
• Strong knowledge of GxP and ICH requirements
• Solid understanding of the pharmaceutical regulatory and publishing processes (e.g., 21 CFR Part 11)
• Ability to work independently and as part of a team
• Experience with standardized open-source R packages for clinical programming in a regulated environment is a plus
• Experience with global health authority submissions is a plus.