Description

Job Purpose

We are seeking a highly skilled and experienced Senior Statistical Programmer to join our Biometric Team. As a Senior Statistical Programmer, you will play a key role in the programming and analysis of clinical trial data, ensuring accuracy, efficiency, and compliance with regulatory standards. This position requires a deep understanding of statistical programming methodologies, clinical trial processes, and regulatory requirements.

Duties and Responsibilities

• Lead the programming activities for clinical trials, including Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM), and Table, Figure, Listing (TFL) programming.
• Ensure high quality and accurate work in the programming process and consistency with the protocol and Statistical Analysis Plan.
• Collaborate with cross-functional teams to develop programming specifications, data validation checks, and analysis plans.
• Provided statistical output for Medical Quality review (MQRs), DSURs, DMC, Interim Report on re-current and adhoc basis.
• Independently validate SDTM & ADaM datasets, produce Define.xml, ADRG and TFLs to ensure the quality and accuracy thus submission readiness of clinical data.
• Review Pinnacle 21 output summaries; review and address pertinent issues.
• Participate in regulatory submissions, including preparation of programming documentation and responses to regulatory inquiries.
• Conduct quality control (QC) reviews of programming code and documentation to ensure compliance with internal standards and regulatory requirements.
• Stay abreast of industry trends, regulatory updates, and advancements in statistical programming methodologies, incorporating best practices into project execution.

Qualifications

• Bachelor's degree in Statistics, Computer Science, or a related field; advanced degree preferred.
• 8-10 years of experience in statistical programming, preferably in the pharmaceutical or biotechnology industry.
• Proficiency in SAS programming, with a strong understanding of SDTM, ADaM, and TFL programming.
• Thorough knowledge of clinical trial processes, regulatory requirements (e.g., FDA, EMA, ICH), and industry standards (e.g., CDISC).
• Proven track record of leading programming activities for complex clinical trials, from protocol development to regulatory submission.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Strong problem-solving skills and attention to detail, with a commitment to delivering high-quality results.
• Ability to work independently, prioritize tasks, and meet deadlines in a fast-paced environment.

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.

Physical Requirements:

This is a largely sedentary role.

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.