Principal Programmer/Associate Manager - Statistical Programming,Central Services

BioSpace; Hyderabad; Hybrid; INR 1,800,000 - 2,400,000; Full time

Job summary

Regeneron in Hyderabad seeks an Associate Manager Statistical Programming Central Services to join our Statistical Programming team in a hybrid work model. You will deliver high-quality programming solutions, support global regulatory submissions, and advance programming processes while collaborating with project programmers, biostatisticians, and cross-functional partners.

The role requires a strong background in SAS, CDISC standards, and experience with regulatory filings, with leadership

Qualifications

• MS in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related
• 6+ years of programming experience with a BS, or 5+ years with an MS, preferably in biotech/pharma
• Project and people management experience
• Experience supporting regulatory submissions and CDISC standards (FDA/EMA/PMDA)
• Proficient SAS programming (Base SAS, SAS/STAT, Macro, Graph)
• CDISC standards (SDTM, ADaM, Define-XML)
• Pinnacle 21 (P21) knowledge
• Familiarity with eCTD submission formats
• R and Python knowledge desirable
• SAS certification a plus
• Excellent communication and collaboration skills

Responsibilities

• Create integrated datasets, pooled analysis datasets, reports and programming docs per standards
• Support electronic data package prep for regulatory submissions ensuring global compliance
• Coordinate with Transparency teams, biostatisticians and cross-functional partners to deliver datasets for disclosures
• Develop tools and standard processes to improve efficiency and compliance
• Troubleshoot programming, validation and submission issues; support procedures across areas
• Assist inspection readiness and respond to inquiries during regulatory inspections
• Collaborate with project programming teams to meet reporting and submission objectives
• Maintain a diligent, problem-solving approach in a fast-paced setting

Job description

Build Our Future TogetherAt Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Manager Statistical Programming Central Services to join our Statistical Programming team, supporting integrated analysis, regulatory submissions, and clinical trial disclosure activities in a hybrid work model. In this role, you will deliver high-quality programming solutions, support global regulatory submissions, and advance programming processes while collaborating with project programmers, biostatisticians, clinical transparency teams, and cross-functional partners. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a significant difference to patients worldwide.

When & Where

Hyderabad, India (Hybrid).

Discover Your Role

• Create integrated datasets, pooled analysis datasets, reports, and programming documentation in line with established standards and processes.
• Support the preparation and review of electronic data packages for regulatory submissions while ensuring compliance with global regulatory and industry standards.
• Coordinate with Clinical Transparency and Trial Disclosure teams, biostatisticians, and cross-functional partners to deliver datasets and outputs required for disclosure activities.
• Provide technical expertise in developing tools, standard processes, and programming solutions that improve efficiency and compliance.
• Troubleshoot programming, validation, and submission-related issues and support the implementation of procedures across assigned areas.
• Support inspection readiness activities and respond to programming-related inquiries during regulatory inspections.
• Collaborate effectively across project programming teams and broader functions to achieve reporting and submission objectives.
• You bring a diligent, problem-solving attitude and thrive in a fast-paced environment with multiple priorities.

This role requires:

• MS (or BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science, or a related discipline.
• 5+ years of programming experience with an MS degree or 6+ years with a BS degree, preferably processing clinical trial data within the biotechnology, pharmaceutical, or health-related industry.
• Project and people management experience.
• Proven experience supporting regulatory submissions and compliance with global standards, including CDISC, FDA, EMA, and PMDA requirements.
• Proficient SAS programming skills in a clinical data environment, including Base SAS, SAS/STAT, Macro, and Graph.
• Strong expertise in CDISC standards, including SDTM, ADaM, and Define-XML.
• Proficiency with Pinnacle 21 (P21), including reviewing and troubleshooting validation reports and issues.
• Familiarity with electronic Common Technical Document (eCTD) submission formats.
• Knowledge of open-source programming languages such as R and Python is highly desirable.
• SAS certification is a plus.
• Excellent communication, interpersonal, collaboration, problem-solving, and organizational skills, with strong attention to detail and the ability to manage multiple priorities.

Does this sound like you? We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• family support benefits

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.