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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.

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 time

Affiliated Companies

Affiliated Companies: PharmaLex India Private Limited

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

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.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [HIDDEN TEXT]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Manager, Statistical Programming