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Planet Pharma · 15 hours ago

Associate Director of Data Standards & Statistical Programming

South San Francisco, CA

Full-time

Onsite

Lead/Staff, Director/Executive

12+ years exp

Planet Pharma is seeking an Associate Director of Data Standards & Statistical Programming who will be responsible for planning and tracking statistical programming activities, including SAS macro development. The role involves overseeing clinical data listings and collaborating with various teams to ensure adherence to standards and high-quality results.

BiotechnologyHealth CarePharmaceutical

H1B Sponsor Likely

Responsibilities

Planning and tracking the statistical programming activities including SAS macro development at program level and study level

Coordinating tasks across multiple studies within a program collaborating with CRO, Biostatistics and Data management on key deliverables

Ensuring the latest CDISC standards are implemented and followed

Designing, developing and validating computer programs to analyze clinical data. Defining departmental standards and SOPs as needed

Overseeing and managing the workflow of required clinical data listings, summary tables, figures and Define.xml files on the program

Mentor junior programmers assigned to the project

Manage all statistical programming activities at program and study level

Oversee the work of programmers to ensure high quality accurate results

Act as a liaison between statistical programming, data management, and biostatistics and plan for optimal workflow and outcomes

Exercise independent judgment in developing SOPs, Work Instructions and Processes to enable production of high-quality results

Perform statistical analysis to enable interpretation of clinical trial results

Create SDTM, ADaM, SAS transport files, Define.xml, Pinnacle 21 reports and reviewer guides for electronic submissions worldwide

Generate safety and efficacy tables, listings, and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, and SAS/ODS

Develop Data set specifications and review TLF Shells

Review Data Management Plan, Data validation plan, and edit check specifications

Qualification

SAS programmingCDISC SDTM/ADaM standardsStatistical analysisClinical trial dataOncology clinical trialsR programmingPythonMentoringCollaboration

Required

MS. (in mathematics, statistics, computer science or equivalent) with 12+ year statistical programming experience in Bio-Pharma industry using SAS to analyze clinical trial data in Phase I/II/III clinical trials

At least 8 years of experience using CDISC SDTM and ADAM standards and minimum of 4 years in oncology clinical trials, using RECIST to derive key primary and secondary endpoints

Experience in developing datasets and outputs for integrated summaries (ISE/ISS) as statistical programming lead on NDA filings

At least 4 years in fast paced small or medium biotech is required

Solid knowledge of SAS programming language, strong SAS programming and statistical background along with proficiency in SAS Base, SAS/Macros, SAS/Graph and SAS/Stat

Preferred

Knowledge of R programming and/or python is a plus

Company

Planet Pharma

Planet Pharma is a pharmaceuticals company.

Founded in 2009

Northbrook, Illinois, USA

1001-5000 employees

http://planet-pharma.com

H1B Sponsorship

Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2022 (3)

2021 (5)

2020 (5)

Funding

Current Stage

Late Stage

Leadership Team

Cynthia Lewis

Senior Executive Recruiter, Life Sciences - PPG Advisory Partners

Emma Morris

President, PPG Advisory Partners

Company data provided by crunchbase