Manager, Statistical Programming

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

📋 Description

• Independently design, validate, and sustain SAS/R programs.

• Create analysis datasets and generate TFLs for clinical studies and regulatory submission requirements.

• Develop and validate datasets compliant with SDTM and ADaM according to specifications and study needs.

• Program, produce, and conduct quality checks on efficacy and safety TFLs in accordance with SAPs, mock shells, and internal guidelines.

• Execute statistical programming using SAS and R.

• Contribute to programming outputs across various studies or projects.

• Collaborate with Biostatistics, Data Management, Clinical, and other cross-functional teams to address data challenges and support study goals.

• Generate and maintain programming documentation, specifications, and standardized procedures.

• Contribute to process enhancements, standardization, and the development of reusable programming tools such as macros and templates.

• Ensure the timely provision of high-quality programming deliverables within a clinical development setting.

• Offer technical support and daily assistance to junior programmers or colleagues.

• Engage in code reviews, debugging, and validation processes.

• Validate and troubleshoot code written by other team members.

• Uphold project quality and adherence to timelines.

⛳️ Requirements

• A Master’s or Bachelor’s degree in Data Science, such as Statistics, computational biology, bioinformatics, computer science, or a related field.

• Extensive experience in CDISC-compliant statistical programming using SAS.

• Strong comprehension of CDISC standards, including SDTMIG and ADaMIG.

• Proven experience in developing efficacy and safety TFLs.

• Solid understanding of clinical trial processes, clinical data structures, and statistical reporting needs.

• Capacity to work autonomously while juggling multiple priorities and deadlines.

• Excellent problem-solving, organizational, and communication skills.

• Comfortable operating across various phases of clinical development and able to adapt quickly.

• Strong grasp of clinical trial design, data analysis, and regulatory requirements.

• Exceptional problem-solving abilities and meticulous attention to detail.

• Minimum of 7+ years of pertinent experience in clinical statistics within the industry (pharmaceuticals, biotechnology, or CRO).

• Preferred: Experience collaborating with international teams remotely.

• Preferred: Statistical background or knowledge.

• Preferred: Experience with submission-related deliverables such as Define.xml, SDRG, ADRG, P21 reports, or related documentation.

• Preferred: Experience with integrated summaries of safety (ISS) and efficacy (ISE).

🏝️ Benefits

• Benefit offerings outside the US may differ by country and will align with local market practices.

• Equal employment opportunity and non-discriminatory practices in recruiting, training, compensation, benefits, promotions, and transfers.

• Reasonable accommodations during the employment process for individuals with disabilities.