Principal Statistical Programmer

Company: HCPro, Inc.
Location: Cambridge
Posted on: September 16, 2020

Job Description:

Reporting to the Head of Biostatistics, Syros Pharmaceuticals is seeking a Principal Statistical Programmer to provide statistical programming support for the clinical programs within drug development at Syros .

Responsibilities:

Work closely with Biostatisticians and other statistical programmers, and interact with members of the multidisciplinary project teams to provide statistical programming support for clinical programs/trials

Provide input in statistical analysis plan and assist in the preparation of output shells

Develop/review dataset specifications per CDISC SDTM and convert raw datasets to SDTM datasets

Develop/review analysis dataset specifications per CDISC ADaM and generate or validate the analysis datasets

Develop SAS programs to generate or validate the statistical outputs for clinical study reports, investigator’s brochures, development safety update reports, submission documents, internal/external presentations, manuscripts for publication, etc.

Ensure that all programs, outputs, and documentation are consistent with ICH guidelines and are conducted in compliance with company SOPs

Run CDISC validation reports to ensure SDTM and AdaM datasets are CDISC compliant

Develop, validate, and maintain global SAS macros to increase programming efficiency

Provide input in CRF designs and CRF completion guidelines and work closely with data management to ensure quality of the clinical database

Monitor project timelines and evaluate programming resource needs

Provide oversight of statistical programming activities of external vendors to ensure timeliness and quality delivery of SDTM datasets, analysis data, and/or statistical outputs

Participate in the improvement and implementation of the statistical programming processes and guidelines

Success Factors

Possesses a sense of urgency and an ability to anticipate and respond quickly to emerging information

Confident and self-motivated with the ability to work independently and act with initiative to address issues

Entrepreneurial and passionate; enjoys working in a fast-paced, small-company environment

Strong organizational and time/project management skills with ability to concurrently provide statistical programming support for multiple clinical trials

Excellent oral and written communication skills for effectively interfacing with vendors and internal stakeholders

Team player, with ability to work effectively with cross-functional teams in a matrix environment

Excellent attention to detail, analytical and problem-solving skills

Acts with integrity and respect always

Requirements

Job Requirements

BS (or equivalent) degree in biostatistics, statistics, mathematics, computer science or related discipline; MS is preferred

6+ years of relevant pharmaceutical/biotechnology industry work experience in statistical programming

Minimum 2 years of experience in oncology drug development desired

Advanced experience in clinical trial reporting using SAS including SAS/Base, SAS/Stat, SAS Macros and SAS/Graph

Knowledge of CDISC SDTM and ADaM models and experience in developing dataset and programming specifications, transforming raw data into these standards, and generating statistical outputs

Knowledge of Good Clinical Practice, Good Programming Practice, and standard statistical programming processes

Experience working with electronic data capturing system and knowledge of data flow in clinical trials

Ability to identify data issues and communicate with data management and the clinical team

Hands-on experience with Patient Profile desired

Experience developing utility macros and knowledge regarding software validation and system development life cycle concepts desired

Previous experience overseeing programming services provided by CROs desired

Finally, the candidate will need to embrace our values:

As one team, strengthened by our diversity, we:

Value each day of patients’ lives

Operate with integrity and respect

Inspire excellence in all

Communicate transparently

Embrace big challenges

EEO Statement.

Syros Pharmaceuticals Inc. is an Equal Opportunity employer. All Syros recruiting is conducted in a fair and non-discriminatory manner without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

The Syros Diversity, Equity, and Inclusion (DEI) Committee invites you to envision your next role in a community where each and every one is empowered to be their best authentic self. Operating with compassion, humility, advocacy, kindness, respect, and awareness, the DEI committee meets regularly to uphold our commitment to an inclusive and welcoming workplace. We believe the unique talents, backgrounds and perspectives of each Syrosian strengthens our coordinated expression, making our company stronger and helping us to achieve our mission of developing medicines to transform patients’ lives. ?

We are not currently seeking third party assistance with this position.

Job Information

Job ID: 54672404

Location:

Cambridge, Massachusetts, United States

Position Title: Principal Statistical Programmer

Syros is redefining the power of small molecules to control the expression of genes. Based on its unique ability to elucidate regulatory regions of the genome, Syros aims to develop medicines that provide a profound benefit for patients with diseases that have eluded other genomics-based approaches. Syros is advancing a robust pipeline of development candidates, including SY-1425, a first-in-class oral selective RAR? agonist in a Phase 2 trial in a genomically defined subset of acute myeloid leukemia patients, and SY-5609, a...

Cambridge, Massachusetts, United States

30+ days ago

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Keywords: HCPro, Inc., Cambridge , Principal Statistical Programmer, Other , Cambridge, Massachusetts