Senior Manager, Statistical Programming

Immunovant; Durham (NC); Remote; USD 175,000 - 195,000; Full time

Job summary

Immunovant, Inc. is seeking a Senior Manager, Statistical Programming to lead programming and statistical analyses for clinical trials and related research. You will validate and cross-check TLGs, contribute to SAPs and publications, and help maintain SAS macro libraries and safety databases.

The role is remote with headquarters in Durham, NC, with ~10% travel; equity and a comprehensive benefits package are available. Expect dynamic, entrepreneurial collaboration across teams and CRO partners.

Qualifications

• Master’s degree plus 7+ years in statistics or statistical programming in biotech/pharma or CRO
• Bachelor’s degree plus 10+ years in statistics or statistical programming in biotech/pharma or CRO
• Excellent SAS programming skills (Base SAS, SAS/Stat, SAS/Graph, SAS macros, ODS) and understanding of database systems
• Experience with CDISC SDTM, ADaM, and eSubmission like define.xml
• Experience coordinating with CROs and leading programming activities
• Strong interpersonal, communication, and organizational skills
• Remote work with HQ in Durham, NC; ~10% travel

Responsibilities

• Interacts with CROs to ensure accurate statistical analyses and deliverables
• Produces timely statistical analyses and programmed outputs for scientific reports
• Maintains internal SAS macro library and safety database
• Provides statistical input for SAPs, publications, and presentations
• Reviews CRFs, SAPs, and TLGs; participates in study team meetings
• Leads CRO selection and evaluation processes
• Creates and reviews derived dataset specifications and analysis datasets
• Develops training guidelines for statistical programming

Skills

SAS programming

CDISC SDTM/ADaM

Leadership

Communication skills

Statistical programming

Education

Master’s degree in quantitative sciences

Bachelor’s degree in quantitative sciences

Tools

SAS macros

define.xml

Job description

Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazers in FcRn inhibitor technology, the Company is boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs.

The Role:

Immunovant is seeking a Senior Manager, Statistical Programming. This position is responsible for performing the programming and statistical analyses necessary to analyze the results of clinical trials and related research activities. This position also contributes to the interpretation of the results of these analyses and provides statistical input for the reporting of the results. This person will also validate and cross-check the relevance and accuracy of the statistical programs and the resulting Tables, Listings and Graphs (TLGs) developed by external Clinical Research Organizations (CROs) and participate in the development and maintenance of SAS macro library and safety database.

Key Responsibilities:

• Interacts with Contract Research Organizations (CROs) involved in data management/analysis activities to ensure that their statistical analyses and resulting outputs are accurate and consistent with the contractually agreed upon deliverables. Works with vendor staff to characterize and resolve issues related to data analysis.
• Produces timely statistical analyses of clinical and related data per protocols and SAPs. Develops statistical programs and produces programmed outputs used to create integrated scientific reports for clinical trial results.
• Participates in the development and maintenance of internal SAS macro library and safety database.
• Provides statistical input for Statistical Analysis Plans (SAPs), publication activities, scientific presentations and promotional material.
• Participates in the review of Case Report Forms (CRFs), CRF annotations, SAPs, and TLG shells and TLGs.
• Participates in study team meetings as a representative of the statistical programming function. Communicates statistical issues and acts as a statistical/programming resource to the development teams.
• Participates in the assessment, selection and evaluation of CROs.
• Creates and reviews derived dataset specifications and the related analysis datasets.
• Develops training guidelines related to statistical programming.

Requirements:

• Master’s degree in a quantitative sciences discipline (e.g., Statistics, Mathematics, Computer Science) and a minimum of 7 years in statistics or statistical programming in a biotech/pharmaceutical or CRO environment.
• Bachelor’s degree in a quantitative sciences discipline (e.g., Statistics, Mathematics, Computer Science) and a minimum of 10 years in statistics or statistical programming in a biotech/pharmaceutical or CRO environment.
• Excellent SAS programming skills (e.g., Base SAS, SAS/Stat, SAS/Graph, SAS macros, ODS) and a good understanding of database systems.
• Experience leading programming activities involving CDISC SDTM, ADaM, and eSubmission (e.g., define.xml, ADRG/SDRG).
• Applied knowledge of clinical data analysis and reporting process as it relates to drug development.
• Excellent interpersonal and communication skills.
• Good organizational skills with the ability to adapt and adjust to changing priorities.
• Experience working with CROs.
• The position will be remote and headquarters based in Durham, NC.
• Dynamic, interactive, fast-paced, and entrepreneurial environment.
• Domestic or international travel may be required (~10%).

Salary range for posting

$175,000 - $195,000 USD

Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in IMVT Corporation’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A \"disabled veteran\" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A \"recently separated veteran\" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An \"active duty wartime or campaign badge veteran\" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An \"Armed forces service medal veteran\" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.