Job Description

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The Company

BioPharma Services Inc. is a subsidiary of Think Research.

BioPharma Services was founded by two surgeons dedicated to advancing medical science to improve the life and spirit of their patients. With this same dedication and vision in mind, these physicians brought life to BioPharma.

Through each success, and even some failures, the perpetual drive to make BioPharma great has been determined by the will and dedication of our people. The will to empower their colleagues, friends and teammates to excel in all facets of clinical research and inspire performance to achieve greatness.

It is with this same culture and brand of excellence that we welcome our clients. To experience the team community that has propelled us into a global leader in medical research, to be a client-focused partner, where people and patients matter.

Again, we invite you to come and meet our people. Our people who have learned that success is better achieved and celebrated as a team than as an individual.

Why Us?

• It's not every day that you have the chance to change the way your friends and family are cared for - Make an impact!
• Everything we do - and we do it with passion - is to improve the quality of life for patients who benefit from the clinical trials that we perform for global pharmaceutical companies.
• We're growing, and so will you with leaders who will support your development through mentorship and other opportunities
• Collaborative, creative, dynamic and flexible work environment, with a start-up spirit

The Role

The statistical programmer performs all SAS programming tasks for clinical trial analysis, performs validation for internally developed SAS codes, implements the statistical analysis on the clinical study data, generates the study summary tables, data listings and graphs/figures (TLGs/TLFs) and performs quality control (QC) checks of the statistical outputs (TLGs/TLFs). This position prepares clinical data from multiple sources, creates derived datasets, executes data specifications to transform clinical study data into Clinical Data Interchange Standards Consortium (CDISC)-compliant data sets (SDTM and ADaM), reviews SDTM specifications, and prepares ADaM specifications, define.xml, and works closely with teams to participate in the validation process of SAS programs on various clinical projects as required.

You Will Have The Opportunity To:

• Write SAS codes for the creation of SDTM and ADaM datasets as per SDTMIG & ADaMIG for clinical study data
• Validate SDTM and ADaM datasets and create define.xml file
• Develop and debug simple to complex SAS programs in a timely manner to provide ad hoc flexible and rapid SAS programming
• Work with Biostatisticians to complete the validation of SAS programs on various clinical study data in accordance with validation plan and user requirements specifications as per SOPs
• Execute double programming for newly developed SAS codes and generation of TLFs
• Maintains documentation for SAS programs and validation results
• Perform statistical analysis of clinical trial data and generate statistical tables, graphs/figures, and listings for clinical trial data as per study protocol and statistical analysis plan (SAP)
• Implement quality control (QC) tasks of the statistical outputs: (TLG/Fs) and the checks of SAS program as required according to SOPs
• Review study data reviewer's guide and analysis data reviewer's guide for submitted datasets as per regulatory guidance
• Review study protocols, SAP with mock shells, and clinical study report as assigned.

What You Will Bring:

• Minimum BS (MS preferred) in Computer Science, Statistics, Biostatistics
• Experience at least 2 years in SAS programming including SAS/BASE, SAS/SQL
• and SAS/Macros in the pharmaceutical industry.
• Proficient in the Microsoft Office
• Knowledge and experience of CDISC
• Knowledge of FDA, EMA and Health Canada and ICH regulations and
• guidelines preferred
• Ability to work effectively as a member of a multidisciplinary research team
• Ability to work creatively and analytically in a problem-solving environment
• Ability to prioritize multiple projects and to work with tight deadlines while
• maintaining high standards

Think Research and all subsidiaries are proud to be an equal opportunity employer and is committed to creating a diverse and inclusive workplace, free of discrimination and harassment.

We provide equal employment opportunities (EEO) to all employees and applicants regardless of race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

We are committed to providing accommodations for people with disabilities. Should you require an accommodation, we would like to work with you to meet your needs.

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