Offer summary

Qualifications:

BS in Statistics, Biostatistics, Engineering, Computer Science or equivalent area., 8+ years of experience in statistical programming or data management within the pharmaceutical industry., Excellent SAS Software Programming skills, including Base SAS, SAS/STAT, SAS/GRAPH and macro development., Strong understanding of clinical trial processes and regulatory submission requirements..

Key responsabilities:

Lead statistical programming and regulatory submission activities.

Manage CROs to ensure timelines and quality expectations are met.

Collaborate with other functions to ensure clarity and accuracy of case report forms and project standards.

Create, validate, and document SDTM, ADaM, and TLFs, as well as complex Macros for data analysis.

Job description

ABOUT US

There are more than 9 million immunocompromised people in the United States. Almost half a million of those represent a population that are moderately to severely immunocompromised and at highest risk for severe COVID-19, including stem cell and solid organ transplant patients as well as those with hematologic cancers.

At Invivyd, Inc., we take those numbers very seriously and we come to work each day on a mission to deliver protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates.

Join an incredible team of innovators, disrupters, predictive modelers, and antibody engineers who embrace a shared sense of ownership, a passion to save lives, think boldly and creatively, take targeted risks, are unafraid of failure, and welcome change as a positive catalyst to new opportunities.

Be part of making a difference. Be part of Invivyd.

Position Title: Senior Manager, Statistical Programming

Reporting to our SVP, Biometrics, the Senior Manager of Statistical Programming is a proven leader with robust technical expertise in statistical programming, responsible for ensuring the integrity, quality, and delivery of statistical analyses across the entire portfolio. This individual will lead statistical programming efforts for all compounds and key regulatory submissions (e.g., BLA and MAA). In this role, the Senior Manager will also be instrumental in developing and executing strategic programming plans, including outsourcing, CRO oversight, and the establishment of industry-standard processes.

Responsibilities:

Statistical Programming:

Lead the statistical programming and regulatory submission activities.
Manage CROs to meet timelines and expectation of quality.
Collaborate with other functions to ensure clarity, accuracy and consistency of case report forms (CRFs), develop and comply with project/study programming standards and specifications according to regulatory guidelines.
Create and validate SDTM, ADaM, and TLFs.
Create, validate, and document complex and reusable Macros for Data Cleaning, Validation, Analysis, customized Report and graph generation, and Integration of Data.
Write and review the data specification of SDTM and ADaM data sets.
Track clinical trial milestones and works with vendors for statistical reporting deliverables.
Maintain records for all assigned projects and archiving of trial/project analysis and associated documentation.
Understands and performs in accordance with regulatory standards and drug development principles.
Responsible for the creation and accuracy of Regulatory submission data and clinical summary report package.

Job Requirements:

BS in Statistics, Biostatistics, Engineering, Computer science or equivalent area with 8+ years of experience in statistical programming or data management within the pharmaceutical industry.
Excellent SAS Software Programming skills, including Base SAS, SAS/STAT, SAS/GRAPH and macro development (SAS Certification is required).
Strong understanding of clinical trial processes and statistical programming requirements for regulatory submissions (regulatory submission experience including NDAs/MAAs is required).
Extensive knowledge of CDISC standards (CDASH and SDTM) and CDM Best Practices.
Extensive experience in defining and implementing CDISC compliant SDTM and ADaM data and specifications.
Strong working knowledge of FDA & ICH/GCP regulations and guidelines.

At Invivyd we strive to create a welcoming and inclusive environment. Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics.

Invivyd is proud to be an equal opportunity employer.

We do not accept unsolicited resumes from agencies.

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