Principal Statistical Programmer bei OCUGEN OPCO INC

Description

Job purpose

The Statistical Programmer is a key member of Ocugen’s clinical operations team. This individual will be responsible for providing statistical programming services including development of macros, creation of analytical datasets from raw data, and implementation of advanced statistical methods. The individual should be able to ensure generation of accurate and reproducible results through error-free statistical programming in SAS, R and other programming languages. This individual will work closely with the Head of Biometrics and Head of Clinical Operations, the rest of the team at Ocugen, and CROs to execute the statistical and data needs of the clinical studies.

Duties and responsibilities

• Ensures the accurate programming of data extracts and data displays
• Develops Macro repository for creation of datasets, conducting analyses, and formatting results into TFLs
• Develops programming specifications, including analysis datasets and tables/listings/figures
• Extracts, imports and formats raw datasets from EDC and other sources into SAS
• Creates CDISC compliant datasets, including SDTM, CDASH, ADaM, and SEND with corresponding documentation, including Define-XML
• Creates TFLs for CSRs, Manuscripts, and additional reports
• Provides input on CRFs, EDC, IRT, SAPs and develops corresponding mock-ups of data displays
• Implements experimental statistical methodology into programming languages
• Ensures high quality reproduce-able data and statistical results in a timely manner
• Interface with CRO ensuring data and statistical reporting is secure and timely
• Participate in study and department meetings
• May assist in developing policies and procedures (SOPs)
• Additional tasks and projects as requested

Qualifications

• Minimum MS/MA degree in Biostatistics, Statistics, Computer Science, or a related field
• At least 5 years of experience working as a Statistical Programmer or Data Scientist
• Ability to synthesize results in graphic, oral, and written reports
• Exceptionally strong statistical programming in SAS and R
• Experience programming in other languages, such as SQL, Matlab, Python
• Experience creating macros and implementing advanced statistical techniques
• Strong knowledge of GCPs, ICH, FDA, and CDISC regulatory requirements governing clinical studies
• Experience working with raw data extracts and EDC systems
• Demonstrated attention to detail and outstanding organization skills
• Self-motivated with a commitment to high quality, on-time deliverables

Working conditions

This position operates in an office setting, in person. Remote work will be limited. Job may additionally require incumbent to be available outside of these hours to handle priority business needs.

Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.