Principal Programmer

Sobi•Waltham, MA

12h

About The Position

The Principal Programmer provides communication skills and expertise in the preparation of regulatory, clinical, and marketing documents throughout drug development, post-marketing and life-cycle management. Provides mentoring and support to individual members of the Statistical Programming Team being on the most expert in the field. Drive and support company projects: Data and programming standards Enablement and finalization of regulatory submissions, regulatory response documents and other external clinical documents (e.g. publications) across multiple therapeutics area In-house database preparation and validation (e.g. Analysis datasets). In-house preparation and validation of output (Table, Listing and Figure (TLFs)). Pooling strategy for integrated analysis (pooling of data, ISE/ISS TLFs). Preparation, review and finalization of regulatory document (e.g. Define.xml, Reviewer’s guide …). Deep insight in CDISC standards. Provide strong technical programming support to Data Management. Prepare, support and enable corporate clinical meta-data, external clinical dictionaries (e.g. CDISC CT, MedDRA, and WHO DD) and corporate standard reporting systems: SAS macro utility programs and associated tools. Support clinical studies with programming skills: Review study documents (e.g. protocol, CRF, SAP, and Clinical Study Report) Take ownership and provide sponsor oversight of outsourced studies to CROs Create/review programming documents (e.g. programming plan, specification for datasets and output template) Work closely with Biostatistics to assure output quality by providing comments on SAP and output template In-house preparation and validation of ad-hoc report output, working closely with the project and/or study statistician. Work closely with Data Management to assure data quality by providing ad-hoc QC-analysis. Be the user representative for the internal Statistical programming data storing and computing environment: Provide user needs (Functional Requirements-, User Requirements-, System Design- Specification) and change-requests. Source Code Handling Applications for Version control Define, implement and perform user acceptance test scripts. Define and maintain needs and processes Ensure timely, high-quality deliverables from Statistical Programming in accordance with project milestones and in line with the overall Sobi R&D project portfolio priority Responsible for processing of clinical data required for analysis of clinical trials, Phase I-IV. Develop SAS coding for preparing, processing and analyzing clinical data. Generate and QC summary tables, data listings and graphs for in-house analyses of study data or publications using SAS standard coding practices. Validate work of other programmer/analysts. Create/request tools to improve programming efficiency or quality. Create/review programming plan, specifications for datasets and TLFs. Support data request from other functional group (Biostatistics, Medical Writing, Clinical Development, Drug Safety, Regulatory and Marketing). Act as mentor for junior staff by giving lessons, advice and challenging their SAS code

Requirements

Bachelor of Science (BSc) in Computer Science, Mathematics, Statistics, pharmaceuticals Sciences, Life Sciences and related areas.
A minimum of 10-years experience of Statistical programming in the biotechnology/pharmaceutical industry
Experience of regulatory submission with FDA or PMDA
Experience of regulatory submission with EMA
Excellent written and verbal Communication skills in English
Excellent knowledge of SAS programming and associated features and their applications in pharmaceuticals industry environment, in particular clinical trial data setting and clinical submissions (Base SAS, SAS Macro and SAS Graph)
Familiar with CDISC conventions, i.e. SDTM and ADaM models and related controlled terminologies, and knowledge or some experience using these models
Familiar with common external coding dictionaries (MedDRA and Standard MedDRA Queries, SMQ and WHO DD), knowledge or some experience of other external dictionaries (e.g. SNOMED, WHOART, COSTART and UNII)
Excellent oral and written communication skills
Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results
Excellent application and macro development skills
Extensive knowledge in CDISC data standards and controlled terminology
Highly developed analytical and strategic thinking with an ability to identify key issues
A strong team player, with the ability to work effectively in a team setting and interact with people of different cultural, seniority and functional backgrounds
Sense of accountability and ownership and able to work independently
Good project management and organizational skills
High scientific and ethical integrity
Curiosity and drive to broaden skill and knowledge
English, both oral and written communication

Nice To Haves

Master of Science (MSc) or PhD
Successful track-record of leading complex projects
Extensive knowledge in setting-up data or programming standard in formal companies
Track record of generating new ideas and solutions to data analysis
Swedish or French, both oral and written communication

Responsibilities

Data and programming standards
Enablement and finalization of regulatory submissions, regulatory response documents and other external clinical documents (e.g. publications) across multiple therapeutics area
In-house database preparation and validation (e.g. Analysis datasets).
In-house preparation and validation of output (Table, Listing and Figure (TLFs)).
Pooling strategy for integrated analysis (pooling of data, ISE/ISS TLFs).
Preparation, review and finalization of regulatory document (e.g. Define.xml, Reviewer’s guide …).
Deep insight in CDISC standards.
Provide strong technical programming support to Data Management.
Prepare, support and enable corporate clinical meta-data, external clinical dictionaries (e.g. CDISC CT, MedDRA, and WHO DD) and corporate standard reporting systems: SAS macro utility programs and associated tools.
Review study documents (e.g. protocol, CRF, SAP, and Clinical Study Report)
Take ownership and provide sponsor oversight of outsourced studies to CROs
Create/review programming documents (e.g. programming plan, specification for datasets and output template)
Work closely with Biostatistics to assure output quality by providing comments on SAP and output template
In-house preparation and validation of ad-hoc report output, working closely with the project and/or study statistician.
Work closely with Data Management to assure data quality by providing ad-hoc QC-analysis.
Provide user needs (Functional Requirements-, User Requirements-, System Design- Specification) and change-requests.
Source Code Handling Applications for Version control
Define, implement and perform user acceptance test scripts.
Define and maintain needs and processes
Ensure timely, high-quality deliverables from Statistical Programming in accordance with project milestones and in line with the overall Sobi R&D project portfolio priority
Responsible for processing of clinical data required for analysis of clinical trials, Phase I-IV.
Develop SAS coding for preparing, processing and analyzing clinical data.
Generate and QC summary tables, data listings and graphs for in-house analyses of study data or publications using SAS standard coding practices. Validate work of other programmer/analysts.
Create/request tools to improve programming efficiency or quality.
Create/review programming plan, specifications for datasets and TLFs.
Support data request from other functional group (Biostatistics, Medical Writing, Clinical Development, Drug Safety, Regulatory and Marketing).
Act as mentor for junior staff by giving lessons, advice and challenging their SAS code

Benefits

Competitive compensation for your work
Generous time off policy
Opportunity to broaden your horizons by attending popular conferences
Emphasis on work/life balance
Collaborative and team-oriented environment
Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
A competitive 401(k) match to support your financial future.
Tuition and wellness reimbursements to invest in your personal and professional growth.
A comprehensive medical, dental, and vision package to prioritize your health and well-being.
Additional recognition awards to celebrate your achievements.