What are the responsibilities and job description for the Senior Manager/Associate Director, Statistical Programming position at Codera?

Job Description

Salary : 145,000-170,000

About Codera

Codera is a Tang Capital company that provides in-house end-to-end drug development capabilities for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products.

Position Summary

The Senior Manager / Associate Director, Statistical Programming will contribute to the programming functions associated with the generation of statistical analyses, including creating SDTM and ADaM datasets and TLF generation within the Biometrics group. This individual will participate in the design, development and quality control process for SAS programs used to access, extract, transform, review and analyze clinical data from clinical studies and associated submission of analyses. The Senior Manager / Associate Director, Statistical Programming will participate in departmental technology development and process improvement initiatives.

Essential Duties and Responsibilities

Act as lead programmer on assigned projects
Manage project timelines and schedules of specific phases of projects and contracts with internal personnel and external stakeholders
Monitor and help facilitate vendor deliverables
Effectively design and code SAS programs for assigned clinical projects while consistently meeting objectives of the study
Code complex SAS programs for applications designed to analyze and report complex clinical trial data, as well as for electronic review, exchange, transformation and submission of data in CDlSC, SDTM and ADaM formats
Assist with New Drug Application (NDA), Marketing Authorization Application (MAA) and any other regulatory submissions from a programming position
Perform quality control checks of advanced SAS code and output produced by statistical programmers
Identify problems and develop tools that increase the efficiency and capacity of the statistical programming group (e.g., macros or graphical user interface applications)

Qualifications

Bachelor's degree or higher in biostatistics, mathematics, statistics, computer science or life sciences or a relevant discipline required. Masters degree preferred

Minimum 4 years of relevant pharmaceutical industry work experience required

Ability to write SAS programs from instructions provided by biostatisticians and statistical programmers to create data sets, tables, figures and listings for result reporting of clinical trials for investigational medications

Experience with creating files, documents and analyses necessary to support an electronic submission in eCTD format, including ISS / ISE

Experience with SAS language, procedures and options commonly used in clinical trial reporting including the macro language, BASE SAS, SAS / STAT and SAS / GRAPH

Experience with the CDISC, SDTM, ADaM models and transforming raw data into these standards

Experience working with various types of safety data and coding dictionaries (MedDRA and WHODRL), commonly used by the pharmaceutical industry

Ability to effectively organize and manage multiple assignments with challenging timelines from project start-up through submission

Skilled at performing quality control checks of SAS code and output produced by other statistical programmers

Knowledge of software validation and system development life cycle concepts

Knowledge of FDA and ICH regulations

Outstanding written and verbal communication skills, including the ability to use clear language to explain complex ideas

Ability to establish and maintain collaborative working relationships with internal and external stakeholders

Codera is an equal opportunity employer. Codera is an E-Verify employer.

remote work

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Senior Manager/Associate Director, Statistical Programming

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