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Sr Manager, Statistical Programming

Boston, MA 02108

Posted: 02/20/2023 Category: Pharmaceutical Job Number: 282872-8_1 Salary: $140,000 - $160,000

Job Description

Smith Hanley Associates
Sr Manager, Statistical Programming
$140k - $160k Salary Range
Nihar Parikh- [email protected]

In this role you will work as a functional lead and provide expertise in CDISC submission standards and statistical programming for clinical development projects and studies.
Apply programming methodology to summary and analysis of clinical trial data, develop SAS programs to create and validate CDISC SDTM conformed datasets, ADaM datasets, and TFLs as scoped in the SAP for reporting purposes in the CSR.
Provide recommendations as to CRF design, data management and review plans, and analytic strategy.
Duties will include eSubmission package planning and execution for data submission to global regulatory agencies.
Manage CRO's providing programming support.
Provide responses to inquiries from the FDA and other regulatory authorities, as part of the submission team.

Bachelor's/Master's degree in Computer Science, Statistics, Biostatistics, or a related scientific discipline.
7+ years of statistical programming experience within a global pharma, biotech, or CRO.
Strong expertise on CDISC data standards and proven experience working with CDISC compliant data.
Experience leading SDTM and ADaM datasets as well as knowledge of the clinical drug development process.
Experience with regulatory requirements for data submissions, ICH/GCP guidelines, and knowledge of other regulatory guidelines relating to eSubmission.
Experience using eCTD format for regulatory submissions.
Experience managing CRO's strongly preferred.
Strong programming skills in SAS/R.
Some travel required, up to 10%

Meet Your Recruiter

Nihar Parikh
Executive Recruiter

Nihar specializes in the clinical domain and works across biostatistics, clinical trials/research, data management, health economics/RWE, medical affairs, statistical programming, and other R&D areas within pharma and biotech. He has more than ten years of recruiting experience and attributes his success to the ability to build good relationships, listen attentively, be proactive, continuously self-improve, and show empathy. Nihar plans to carry Smith Hanley’s stellar reputation in the pharma business for many years to come. Outside of work, Nihar likes to spend his time following Chicago sports, travel, podcasts, yoga, golf, and investing. 

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