Manager, Statistical Programming
Confirmed on the employer's own hiring board on Oct 30, 2026. First seen by Alion on Sep 28, 2026. Cencora scores B on the Alion truth index.
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Job Details
Job Summary:
We are looking for an experienced Statistical Programmer with strong hands-on expertise in SAS programming and deep knowledge of CDISC standards, including SDTM and ADaM. This role will be responsible for independently developing, validating, and maintaining SAS/R programs including development of analysis datasets and production of TFLs to support clinical studies and regulatory submission deliverables, with oversight and guidance responsibilities. It requires a deep understanding of clinical trial design and data analysis.
Key Responsibilities:
- Develop and validate datasets in compliance with dataset specifications following CDISC standards (SDTM and ADaM) and study requirements.
- Program, generate, and quality check TFLs for efficacy and safety analyses for clinical study report or regulatory submissions following SAP, mock shells and internal standards.
- Perform SAS and R statistical programming.
- Contribute to the preparation and review of programming deliverables across multiple studies or projects.
- Collaborate closely with Biostatistics, Data Management, Clinical, and other cross-functional teams to resolve data issues and support study objectives.
- Support creation and maintenance of programming documentation, specifications, and standard processes.
- Contribute to process improvements, standardization efforts, and development of reusable programming tools such as macros and templates.
- Ensure timely delivery of high-quality programming outputs in a fast-paced clinical development environment.
- Provide technical guidance and day-to-day support to junior programmers or peers as needed.
- Participate in code review, debugging, and validation activities to support quality and consistency across programming deliverables.
- Validating/debugging the codes written by other team members.
- Maintain quality and timeliness of project work.
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Qualifications:
- Master's or Bachelor’s degree in Data Science such as Statistics, computational biology, bioinformatics, computer science, or a related field
- High experience in CDISC-compliant statistical programming in SAS, with the aim of increasing efficiency.
- Strong understanding of CDISC standards, including SDTMIG and ADaMIG.
- Demonstrated experience in developing efficacy and safety TFLs.
- Good understanding of clinical trial processes, clinical data structures, and statistical reporting requirements.
- Ability to work independently while managing multiple priorities and deadlines.
- Strong problem-solving, organizational, and communication skills.
- Comfortable working across multiple phases of clinical development and able to shift gears quickly.
- Strong understanding of clinical trial design, data analysis, and regulatory requirements.
- Excellent problem-solving skills and attention to detail.
Preferred Qualifications:
- Experience of working with international teams remotely is a plus.
- Statistical background or knowledge is a plus.
- Experience with submission-related deliverables such as Define.xml, SDRG, ADRG, P21 reports or related documentation is a plus
- Experience with integrated summaries of safety (ISS) and efficacy (ISE) is a plus.
Experience:
- Minimum of 7+ years of relevant experience in clinical statistics in industry (pharmaceuticals, biotechnology, or CRO).
What Cencora offers
Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.
Full timeAffiliated Companies
Affiliated Companies: PharmaLex India Private LimitedEqual Employment Opportunity
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The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
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